Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present

Drug Sponsor Sponsor Medical Review Clinical Pharmacology Review Statistical Review BPCA or PREA or Both Abametapir - Xeglyze HATCHTECH PTY LTD

Medical (PDF - 4 MB)

Addendum (PDF - 78 KB)

CDTL (PDF - 3 MB)

Resubmission (PDF - 77 KB)

DD (PDF - 2 MB)

Clinical pharmacology (PDF - 6 MB) Statistical (PDF - 207 KB) PREA Abacavir and Lamivudine - Epzicom ViiV Healthcare Company Medical (PDF - 3 MB) Clinical pharmacology (PDF - 158 KB) Statistical (PDF - 693 KB) PREA Abacavir, Dolutegravir, and Lamivudine - Triumeq ViiV Healthcare Company Medical (PDF - 443 KB) Clinical pharmacology (PDF - 128 KB) None PREA Abacavir, Dolutegravir, and Lamivudine - Triumeq 
  ViiV Healthcare Company c/o GlaxoSmithKline

Medical (PDF - 389 KB)

CDTL (PDF - 798 KB)

Clinical pharmacology (PDF - 128 KB) None PREA Abacavir, Dolutegravir, and Lamivudine - Triumeq PD ViiV Healthcare Company CDTL (PDF - 758 KB) Clinical pharmacology (PDF - 3 MB) None BOTH Abacavir sulfate - Ziagen ViiV Healthcare Company Medical (PDF - 4.2 M B) Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 5 MB) PREA Abatacept - Orencia Bristol-Myers Squibb Company

Medical (PDF - 259 KB)

Medical Addendum (PDF - 469 KB)

Clinical pharmacology (PDF - 2 MB)

Clinical pharmacology (PDF - 269 KB)

None BOTH Abatacept - Orencia Bristol-Myers Squibb Company Medical (PDF - 4 MB) None None BPCA AbobotulinumtoxinA - Dysport Ipsen Bipharm Limited CDTL Review (PDF - 2 MB)

Medical (PDF - 3 MB)

None Statistical (PDF - 2 MB) PREA AbobotulinumtoxinA - Dysport Ipsen Bipharm Limited Medical (PDF - 1 MB) None Statistical (PDF - 857 KB) PREA Abrocitinib - Cibinqo
  Pfizer Inc. Medical (PDF - 10 MB) None None PREA Abrocitinib - Cibinqo Pfizer Inc. Medical (PDF - 5 MB) None None PREA Acetaminophen - Ofirmev MallInc.krodt, Inc. Medical (PDF - 1 MB) Clinical pharmacology (PDF - 5 MB) Statistical (PDF - 378 KB) BOTH Acetylcysteine - Legubeti Galephar Pharmaceutical Research Inc.

Unireview (PDF - 6 MB)

Unireview CR (PDF - 10 MB)

None None PREA Acyclovir 5%, hydrocortisone 1% - Xerese   Valeant International Bermuda Medical (PDF - 885 KB) None None PREA Adalimumab-adaz - Hyrimoz
  Sandoz Inc.

Medical (PDF - 2 MB)

CDTL Review (PDF - 300 MB)

None None PREA

Adalimumab-adaz - Hyrimoz

Sandoz Inc.

CDTL Review (PDF - 342 KB)

None None PREA Adalimumab-adaz - Hyrimoz Sandoz Inc. CDTL Review (PDF - 34 KB) None None PREA Adalimumab-adbm - Cyltezo Boehringer Ingelheim Medical (PDF - 826 KB) None None PREA Adalimumab-afzb - Abrilada  Pfizer Inc. CDTL (PDF - 34 KB) None None PREA Adalimumab-afzb - Abrilada  Pfizer Inc. Medical (PDF - 1 MB) None None PREA Adalimumab-afzb - Abrilada Pfizer Inc. CDTL (PDF - 34 KB) None None PREA Adalimumab-aqvh - Yusimry   Coherus BioSciences, Inc Medical (PDF - 5 MB) None None PREA Adalimumab-aqvh - Yusimry Coherus BioSciences, Inc CDTL Review (PDF - 342 KB) Clinical pharmacology (PDF - 22 KB) None PREA Adalimumab-atto - Amjevita Amgen Inc.

CDTL Review (PDF - 4.3 MB)

Medical (PDF - 199K KB)

Medical (PDF - 336KB)

DD Summary Review (PDF - 3 MB)

Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 416 KB)

Statistical  (PDF - 363 KB)

Statistical (PDF - 717 KB)

 PREA Adalimumab-aaty - Yuflyma Celltrion, Inc. CDTL - DD (PDF - 356 KB) Clinical pharmacology (PDF - 2 MB) None PREA Adalimumab-atto - Amjevita Amgen, Inc CDTL (PDF - 580 KB) None None PREA Adalimumab-atto - Amjevita Amgen, Inc Medical (PDF - 532 KB) None None PREA Adalimumab-atto - Amjevita 
  Amgen, Inc Medical (PDF - 532 KB) None None PREA Adalimumab-atto - Amjevita Amgen Inc. Medical (PDF - 25 KB) None None PREA Adalimumab-bwwd - Hadlima Samsung Bioepis Co., Ltd. Medical (PDF - 34 KB) Clinical pharmacology (PDF - 1 MB) None PREA Adalimumab-bwwd - Hadlima Samsung Bioepis Co., Ltd. Medical (PDF - 34 KB) None None PREA Adalimumab-fkjp - Hulio Mylan Pharmaceuticals Inc. Medical (PDF - 2 MB) None None PREA Adalimumab-fkjp - Hulio
  Mylan Pharmaceuticals Inc. Medical (PDF - 580 KB) None None PREA Adalimumab-fkjp - Hulio Mylan Pharmaceuticals Inc. CDTL (PDF - 24 KB) None None RPEA Adalimumab - Humira AbbVie,Inc. Medical (PDF - 2 MB) None None PREA Adalimumab-aacf - Idacio Fresenius Kabi USA, LLC Medical (PDF - 20 MB) None None PREA Adalimumab-aacf - Idacio Fresenius Kabi USA, LLC Medical (PDF - 20 MB) None None PREA Adapalene and benzoyl peroxide - Epiduo Galderma Laboratories, LP Medical (PDF - 2 MB) Clinical pharmacology (PDF -124 KB) Statistical (PDF - 577 KB) PREA Adapalene and benzoyl peroxide - Epiduo Forte Galderma Research and Development LLC Medical (PDF - 6.2 MB) Clinical pharmacology (PDF - 4 MB) Statistical (PDF - 2 MB) PREA

Afatini - Gilotrif

Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF - 5 MB) None None BPCA Aflibercept - Eylea
  Regeneron Pharmaceuticals, Inc. Medical (PDF - 1 MB) Clinical pharmacology (PDF - 2 MB) Statistical (PDF - 5 MB) BPCA Anidulafungin - Eraxis Vicuron Holdings LLC, a subsidiary of Pfizer Inc. Medical (PDF - 5 MB) None None PREA Albuterol and Budesonide - Airsupra  Bond Avillion 2 Development LP Medical (PDF - 12 MB) None None PREA Albuterol sulfate - ProAir RespiClick Teva Pharmaceutical Products R. & D., Inc. Medical (PDF - 3 MB) Clinical pharmacology (PDF - 4 MB) Statistical (PDF - 2 MB) PREA Albuterol sulfate - ProAir RespiClick  Teva Branded Pharmaceutical Products R&D, Inc. Medical (PDF - 859 KB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 1 MB) PREA Alirocumab - Praluent Regeneron Pharmaceuticals, Inc Medical (PDF - 859 KB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 1 MB) PREA Aliskiren - Tekturna Noden Pharma DAC CDTL (PDF - 310 KB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 442 KB) BOTH Alogliptin - Nesina Takeda Pharmaceuticals U.S.A., Inc Medical (PDF - 6 MB) Clinical pharmacology (PDF - 937 KB) Statistical (PDF - 536 KB) PREA Alogliptin and metformin - Kazano Takeda Pharmaceuticals U.S.A., Inc. Medical (PDF - 6 MB) Clinical pharmacology (PDF - 937 KB) Statistical (PDF - 536 KB) PREA

Amlodipine benzoate - Katerzia

Silvergate Pharmaceuticals, Inc Medical (PDF - 46 KB) Clinical pharmacology (PDF - 337 KB) None

PREA

Amphetamine - Adzenys ER Neos Therapeutics, Inc. Medical (PDF - 1.9 MB) Clinical pharmacology (PDF - 4 KB) None PREA Amphetamine Extended-Release Orally Disintegrating Tablets - Adzenys XR-ODT  Neos Therapeutics, Inc. Medical (PDF - 470 KB) Clinical pharmacology (PDF -3 MB) None PREA Amphetamine - Dyanavel XR Tris Pharma Medical (PDF - 1.8 MB) Clinical pharmacology (PDF - 5 MB) Statistical (PDF - 767 KB) PREA Amphetamine - Dyanavel XR Tris Pharma

Medical (PDF - 848 KB)

CDTL Review (PDF - 1 MB)

None None  PREA

Amphetamine sulfate - Evekeo

Arbor Pharmaceuticals, LLC

Medical (PDF - 1 MB)

Medical (PDF - 155 KB)

Clinical pharmacology (PDF - 9 KB)

Clinical pharmacology memo (PDF - 9 KB)

Statistical (PDF - 532 KB) PREA Apremilast - Otezla Amgen, Inc Medical (PDF - 7 MB) None None PREA Aprepitant - Emend Merck Sharp & Dohme Corp. Medical (PDF - 6 MB)

Medical Addendum (PDF -1 MB)

Medical DD memo (PDF - 3 MB)

Clinical pharmacology (PDF - 5 MB)

Clinical pharmacology addendum (PDF - 424 KB)

Statistical (PDF - 1 MB) PREA Aprepitant - Emend Merck Sharp & Dohme Corp. Medical (PDF - 553 KB) Clinical pharmacology (PDF - 5 MB)

Addendum (PDF -105 KB)

Statistical (PDF - 1 MB) PREA Aripiprazole - Abilify Otsuka Medical (PDF - 2.4MB) None Statistical (PDF - 409 KB) PREA Asenapine - Saphris Forest Laboratories, Inc. Medical (PDF - 5 MB)

Medical (PDF - 4 MB)

Clinical pharmacology (PDF - 4 MB) Statistical (PDF - 3 MB) BOTH Asparaginase erwinia chrysanthemi (recombinant)- rywn - Rylaze Jazz Pharmaceuticals Ireland Limited Medical (PDF - 4 MB) None None PREA Atazanavir and cobicistat - Evotaz Bristol-Myers Squibb Company CDTL (PDF - 402 KB) Clinical pharmacology (PDF -1 MB) None PREA Atazanavir - Reyataz Bristol-Myers Squibb Company Medical (PDF - 14 MB) Clinical pharmacology (PDF -1 MB) Statistical (PDF - 2 MB) BOTH Atazanavir - Reyataz  Bristol-Myers Squibb Company Medical (PDF - 2 MB) Clinical pharmacology (PDF - 1 MB) Statistical (PDF - 4 MB) BOTH

Atezolizumab - TECENTRIQ

Genentech, Inc. Medical (PDF - 1 MB) None None BPCA

Atezolizumab - Tecentriq

Genentech, Inc. Medical (PDF - 3 MB) None None BPCA Atorvastatin calcium - Atorvaliq CMP Development LLC Medical (PDF - 3 MB) Clinical pharmacology (PDF - 1 MB) None PREA

Atropine-pralidoxime - DueDote

Meridian Medical Technologies, Inc.

CDTL (PDF - 402 KB)

Medical (PDF - 886 KB)

Clinical pharmacology (PDF - 1 MB) None PREA Atropine Sulfate - Isopto Atropine 1% Alcon Research, Ltd. Medical (PDF - 663KB) Clinical pharmacology (PDF - 480KB) Statistical (PDF - 230KB) PREA Atropine Sulfate Ophthalmic Solution Akorn, Inc. Medical (PDF - 1.2 MB) Clinical pharmacology (PDF - 1MB) Statistical (PDF - 287KB) PREA Azelastine hydrochloride - Astepro Meda Pharmaceuticals Clinical (PDF -1 .4MB) None Statistical (PDF -473 KB PREA Azelastine hydrochloride - Astepro Meda Pharmaceuticals Inc. Medical (PDF - 2MB) None None BOTH Azelastine hydrochloride and Fluticasone propionate - Dymista Meda Pharmaceuticals, Inc. Medical (PDF - 2.9MB) None Statistical (PDF -2.1MB) BOTH Baclofen - Fleqsuvy Azurity Pharmaceuticals, Inc. Medical (PDF - 2 MB) Clinical pharmacology (PDF - 367 KB) None PREA Baclofen - Lyvispah Saol Therapeutics Research Limited Medical (PDF - 2 MB) Clinical pharmacology (PDF - 448 KB) None PREA

Baloxavir marboxil - Xofluza

Shionogi, Incorporated

 

CDTL (PDF - 869 KB)

Medical (PDF - 414 KB)

Clinical pharmacology (PDF - 3 MB) Statistical (PDF -  2 MB)   PREA Baloxavir marboxil - Xofluza Genentech, Incorporated

CDTL (PDF - 853 KB)

Medical (PDF - 6 MB KB)

Clinical pharmacology (PDF - 420 KB) None PREA Baloxavir marboxil - Xofluza Genentech, Incorporated Medical (PDF - 11 MB) None None PREA Barium sulfate - E-Z-HD  Bracco Diagnostics Inc. Medical (PDF - 2.4MB) Clinical pharmacology (PDF -642KB) Statistical (PDF -988KB) PREA Barium sulfate - READI-CAT 2 & READI-CAT 2 SMOOTHIE  Bracco Diagnostics Medical (PDF - 2.4MB) Clinical pharmacology (PDF - 702 KB) Statistical (PDF -1 MB) PREA Barium sulfate  - Varibar Pudding Bracco Diagnostics, Inc. Medical (PDF - 1MB) None None  PREA Barium sulfate - Liquid E-Z-Paque Bracco Diagnostics, Inc. DD Summary Review (PDF - 233 KB) None None PREA Beclomethasone dipropionate - Qnasl Teva Branded Pharmaceutical Products R&D, Inc. Medical (PDF - 4 MB) Clinical pharmacology (PDF - 2 MB) Statistical (PDF -959 KB) PREA

Belumosudil - Rezurock

 

Kadmon Pharmaceuticals, LLC Medical (PDF - 7MB) Non None PREA Belimumab - Benlysta  Human Genome Sciences Medical (PDF - 6 MB) None None PREA Belimumab - Benlysta GlaxoSmithKline LLC Medical (PDF - 7 MB) None None PREA Benralizumab - Fasenra AstraZeneca AB Medical (PDF - 2 MB) Clinical pharmacology (PDF - 7 MB) Statistical (PDF - 2 MB) PREA Benralizumab - Fasenra AstraZeneca AB c/o AstraZeneca Pharmaceuticals LP

Medical (PDF - 7 MB)

Unireview (PDF - 11 KB)

None None PREA Berdazimer - Zelsuvmi LNHC, Inc. Medical (PDF - 12 MB) None None PREA Bezlotoxumab - Zinplava  Merck Sharp & Dohme Corp. Medical (PDF - 2 MB) None None BOTH Bictegravir, emtricitabine, and tenofovir alafenamide - Biktarvy  Gilead Sciences, Inc.

CDTL (PDF - 157 KB)

CDTL 1 (PDF - 2 MB)

Clinical pharmacology (PDF - 2 MB) None PREA Bictegravir, emtricitabine, and tenofovir alafenamide - Biktarvy Gilead Sciences, Inc.  CDTL (PDF - 2 MB) Clinical pharmacology (PDF - 4 MB) None PREA Bimatoprost ophthalmic solution, 0.03% - Latisse Allergan, Inc. DD Summary Review (PDF - 966KB)

CDTL Review (PDF - 3 MB)

Medical (PDF - 2 MB)

None Statistical (PDF -946KB)

Statistical Addendum (PDF - 127KB)

PREA

Blinatumomab - Blincyto

 

 Amgen, Inc. Medical (PDF - 3 MB) Clinical pharmacology (PDF -1 MB) Statistical (PDF -374 KB) BPCA Blinatumomab - Blincyto Amgen, Inc. Medical (PDF - 9 MB)

None

 

None BPCA Bortezomib - Velcade Millennium Pharmaceuticals, Inc. Medical (PDF - 4 MB) Clinical pharmacology (PDF -1 MB) Statistical (PDF - 374 KB) BPCA Bosutinib - BOSULIF PF Prism C.V Medical (PDF - 10 MB) None None BPCA Budesonide - Entocort EC Elan Pharma International Medical (PDF - 3 MB) Clinical pharmacology (PDF - 3 MB) Clinical pharmacology (PDF - 3 MB) PREA Brentuximab vedotin - Adcetris Seagen Inc. Medical (PDF - 1 MB) None None BPCA

Brexanolone - Zulresso

Sage Therapeutics, Inc. Medical (PDF - 1 MB) None None PREA Brexpiprazole - Rexulti
  Otsuka Pharmaceutical Company, Ltd. Medical (PDF - 4 MB) None None PREA Brimonidine tartrate - Lumify Bausch + Lomb CDTL Review (PDF - 3 MB)

Medical (PDF - 556 KB)

Clinical pharmacology (PDF -  51 KB) Statistical (PDF - 219 KB) PREA Brivaracetam - Briviact  UCB, Inc.

CDTL Review (PDF - 297 KB)

Medical (PDF - 1 MB)

Clinical pharmacology (PDF -  2 MB) None

PREA

 

Brivaracetam - Briviact  UCB, Inc. Medical (PDF - 74 KB) Clinical pharmacology (PDF - 2 MB) None PREA Budesonide/formoterol fumarate dehydrate -  Symbicort AstraZeneca Pharmaceuticals, LP Medical (PDF - 3.4 MB) Clinical pharmacology (PDF - 1.2 MB) Statistical (PDF - 2.5 MB) BOTH Bupivacaine - Exparel Pacira Pharmaceuticals, Inc. Medical (PDF - 6 MB) Clinical pharmacology (PDF - 2 MB) None PREA Buprenorphine - Butrans Purdue Pharma L.P. Medical (PDF - 4.1 MB) Clinical pharmacology (PDF - 1.5 MB) None PREA Cabazitaxel - Jevtana Sanofi-Aventis U.S., L.L.C. Medical (PDF - 1.5 MB) Clinical pharmacology (PDF - 1.2 MB) None BPCA

Cabotegravir - Apretude

ViiV Healthcare Company Medical (PDF - 8 MB) None None PREA Cabotegravir-rilpivirine - Cabenuva
  ViiV Healthcare Company Medical (PDF - 35 KB)

Clinical pharmacology (PDF - 1 MB)

Clinical pharmacology Addendum (PDF - 229 KB)

None PREA Cabotegravir - Vocabria ViiV Healthcare Company

CDTL (PDF - 1 MB)

Medical (PDF - 525 KB)

Clinical pharmacology (PDF - 2 MB)

Addendum (PDF - 115 KB)

None PREA Calcipotriene - SORILUX Foam  Mayne Pharma LLC Medical (PDF - 525 KB) None None PREA Calcipotriene - SORILUX Mayne Pharma LLC Medical (PDF - 525 KB) Clinical pharmacology (PDF - 1.2 MB) None PREA Calcipotriene and Betamethasone dipropionate - Taclonex LEO Pharma A/S Medical (PDF -5.6MB) Clinical pharmacology (PDF -2.4MB) Statistical (PDF -564 KB) PREA Calcipotriene and Betamethasone dipropionate - Taclonex LEO Pharma A/S c/o LEO Pharma, Inc. Medical (PDF - 3.7MB) Clinical pharmacology (PDF -2.7MB) None PREA Calcipotriene and Betamethasone dipropionate - Taclonex LEO Pharma A/S Medical (PDF - 775 KB) Clinical pharmacology (PDF - 528 KB) None PREA Calcipotriene and betamethasone - Enstilar LEO Pharma A/S Medical (PDF - 775 KB) N None BOTH Calcium Gluconate injection - Calcium Gluconate Injection Fresenius Kabi USA, LLC

Medical (PDF - 4 MB)

Medical CTDL (PDF - 1.5 MB)

Clinical pharmacology (PDF - 1 MB) None PREA Calcitriol - Vectical
  Galderma Laboratories, L.P. Medical (PDF - 3 MB) Clinical pharmacology (PDF - 1 MB) None PREA Cantharidin - Ycanth Verrica Pharmaceuticals Inc. Medical (PDF - 3 MB) None None PREA Capecitabine - Xeloda Hoffmann-La Roche, Inc. Medical (PDF - 4MB) Clinical pharmacology (PDF - 1MB) Statistical (PDF -610 KB) BPCA Carbinoxamine maleate - Karbinal ER Tris Pharma, Inc. Medical (PDF - 1.4MB) Clinical pharmacology (PDF - 500 KB) None PREA Cefazolin sodium and dextrose solution - Cefazolin for Injection USP and Dextrose Injection USP in the Duplex® Container B. Braun Medical Inc. Medical (PDF - 1 MB) None None PREA Ceftaroline fosamil - Teflaro  Cerexa, Inc., A Subsidiary of Forest Laboratories, LLC Medical (PDF - 11 MB)

Medical CTDL (PDF - 2 MB)

Clinical pharmacology (PDF - 3 MB) Statistical (PDF -1 MB) PREA Ceftaroline fosamil - Teflaro Allergan Sales, LLC Medical (PDF - 5 MB) None None PREA Ceftazidime and Avibactam - Avycaz Allergan Sales, LLC Medical (PDF - 5 MB) None None PREA Ceftazidime and avibactam - Avycaz  Allergan Sales, LLC Medical (PDF - 4 MB) None None PREA Ceftazidime and avibactam - Avyca AbbVie, Inc. Medical (PDF - 4 MB) None None PREA Ceftobiprole medocaril sodium for injection - Zevtera Basilea Pharmaceutica International, Ltd., Allschwil Medical (PDF - 4 MB) None None PREA Ceftolozane and tazobactam - Zerbaxa  Cubist Pharmaceuticals, LLC Medical (PDF - 8 MB) None None PREA Certolizumab pegol - Cimzia UCB, Inc Medical (PDF - 4 MB) None None PREA Cetirizine ophthalmic solution - Zerviate  Nicox Ophthalmics, Inc.

Medical Resubmission (PDF - 231 KB)

Medical (PDF - 5 MB)

Clinical pharmacology (PDF - 279 KB) Statistical (PDF - 580 KB) BOTH Cetirizine hydrochloride - Quzyttir JDP Therapeutics Inc Medical (PDF - 2 MB) None None PREA Ciclesonide - Zetonna Takeda GmbH

Medical (PDF - 5 MB)

Clinical pharmacology (PDF -1 MB) Statistical (PDF -674 KB) PREA Cinacalcet hydrochloride - Sensipar  

CDTL (PDF - 2.2 MB)

Medical (PDF - 4.1 MB)

Clinical pharmacology (PDF - 5.6 MB) Statistical (PDF - 957 KB) BOTH Ciprofloxacin 0.3% and Fluocinolone acetonide 0.025% - Otovel Otic Solution Laboratorios SALVAT, S.A. Medical (PDF - 4MB) Clinical pharmacology (PDF -632 KB) Statistical (PDF -2MB) PREA Ciprofloxacin otic suspension - Otiprio  Otonomy, Inc. Medical (PDF -  233 KB) Clinical pharmacology (PDF - 79 KB) Statistical (PDF -  213 MB PREA 6% Ciprofloxacin Otic Suspension - Otiprio Otonomy, Inc. Medical (PDF - 2.3MB) Clinical pharmacology (PDF - 97 KB) Statistical (PDF -896 KB)

Addendum (PDF -157 KB

PREA Ciprofloxacin ophthalmic solution - Ciloxan Novartis Pharmaceuticals Corporation

Medical (PDF - 110 KB)

Medical (PDF - 173 KB)

None None BPCA 

Clascoterone - Winlevi

Cassiopea SpA Medical (PDF - 3 MB) None None PREA

Clindamycin phosphate, adapalene, and benzoyl peroxid - Cabtreo

Bausch Health US, LLC Medical (PDF - 4 MB) None None PREA Clindamycin phosphate -  Xaciato  Daré Bioscience Inc. Medical (PDF - 3 MB) None None PREA Clonidine - Kapvay Concordia Pharms Inc. Medical (PDF - 3 MB) None Statistical (PDF -2MB) PREA Cobicistat - Tybost Gilead Sciences, Inc. CDTL (PDF - 1 MB) Clinical pharmacology (PDF - 1 MB) None BOTH Cobimetinib - Cotellic
  Genentech, Inc. Medical (PDF - 27 KB) Clinical pharmacology (PDF - 543 KB) None BPCA Colesevelam HCl - Welchol Daiichi Sankyo Inc. CDTL (PDF - 2 MB)

Medical (PDF - 12MB)

Clinical pharmacology (PDF - 7 MB) None PREA Colesevelam HCl - Welchol Daiichi Sankyo Inc. Medical (PDF - 3 MB) None Statistical (PDF - 308 KB) PREA Crisaborole Ointment, 2% - Eucrisa Anacor Pharmaceuticals Inc. CDTL Review (PDF - 2MB)

Medical (PDF - 12MB)

Clinical pharmacology (PDF - 7MB) Statistical (PDF - 1MB) PREA Crisaborole - Eucrisa Anacor Pharmaceuticals, LLC. Medical (PDF - 2 MB) None None PREA Crisaborole - Eucrisa Pfizer Medical (PDF - 1 MB) Clinical pharmacology (PDF - 1 MB) None BPCA Cysteamine bitartrate - Procysbi Raptor Pharmaceuticals, Inc. Medical (PDF -12MB) Clinical pharmacology (PDF - 2 MB)

Clinical pharmacology addendum (PDF - 420 KB)

None BPCA Cysteamine bitartrate - Procysbi Horizon Pharma USA, Inc.
  Medical (PDF - 2 MB) Clinical pharmacology (PDF - 1 MB) Statistical (PDF - 1 MB) BPCA Cysteamine hydrochloriden - CYSTADROPS Recordati Rare Diseases Inc. Medical (PDF - 294 KB) None None PREA Dabigatran etexilate - Pradaxa 
  Boehringer Ingelheim Pharmaceuticals, Inc.

Medical (PDF - 2 MB)

Medical (PDF - 700 KB)

Clinical pharmacology (PDF - 5 MB) None BOTH Dabrafenib - Tafinlar Novartis Pharmaceuticals Corporation Medical (PDF - 18 MB) None None PREA Dabrafenib - Tafinlar Novartis Pharmaceuticals Corporation Medical (PDF - 10 MB)

CDTL (PDF - 1 MB)

Clinical pharmacology (PDF - 579 KB) None BPCA

Dalbavancin hydrochloride - Dalvance

Allergan Sales, LLC Medical (PDF - 2 MB) None None PREA Dalteparin sodium - Fragmin Pharmacia & Upjohn, a subsidiary of Pfizer Inc. Medical (PDF - 3.5 MB) None None PREA Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide - Symtuza Jannsen Medical (PDF - 3.5 MB) Clinical pharmacology (PDF - 1.2MB) None PREA Dapsone - Aczone Allergan, Inc. Medical (PDF - 3.5 MB) Clinical pharmacology (PDF -  2.6 MB) Statistical (PDF -1.3 MB) PREA Dapsone - Aczone Almirall, LLC Medical (PDF - 3.5 MB) Clinical pharmacology (PDF -  2.6 MB) None PREA Daptomycin - Cubicin Cubist Pharmaceuticals, LLC c/o Merck Sharp & Dohme Corp. Medical (PDF - 505 KB) Clinical pharmacology (PDF - 1.8 MB)

 

Statistical (PDF -1.9 KB)

Statistical Addendum (PDF - 96 KB)

PREA Daptomycin - Cubicin Cubist Pharmaceuticals, LLC c/o Merck Sharp & Dohme Corp. Medical (PDF - 389 KB)

Clinical pharmacology (PDF - 991 KB)

Clinical pharmacology Addendum (PDF - 80 KB)

Statistical (PDF - 374 KB)

 

PREA  Daptomycin - Dapzura RT
  Baxter Healthcare Corporation Medical (PDF - 2 MB) None None PREA Darbepoetin alfa - Aranesp Amgen Inc. Medical (PDF - 2 MB) None Statistical (PDF -280KB) BPCA Darunavir and Cobicistat - Prezcobix Janssen Products, LP Medical (PDF - 147 KB) Clinical pharmacology (PDF - 20 KB) None PREA Darunavir - Prezista Janssen Products, L.P. Medical (PDF -1MB) Clinical pharmacology (PDF -1MB) None PREA Darunavir - Prezista Janssen Products, L.P. None Clinical pharmacology (PDF -352KB) None PREA Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide - Symtuza  Janssen Products, L.P. Multi-disciplinary review (PDF - 8 MB) None None  PREA

Dasatinib - Sprycel 

 

Bristol-Myers Squibb Company

CDTL Review (PDF - 1 MB)

Medical (PDF- 8 MB)

Clinical pharmacology (PDF - 531 KB)

Statistical (PDF - 19 KB) BPCA  Dasiglucagon - Zegalogue   Zealand Pharma A/S Medical (PDF - 5MB)

Clinical pharmacology (PDF - 33KB)

Clinical pharmacology Addendum (PDF - 38KB)

Statistical (PDF - 2MB) PREA Daunorubicin and cytarabine (liposome injection) - Vyxeos  Jazz Pharmaceuticals Multidisciplinary (PDF - 5 MB) None None BPCA Decitabine - Dacogen  Eisai Inc. Medical (PDF -2 MB) Clinical pharmacology (PDF -1MB) None BPCA Deferasirox - Exjade Novartis Pharmaceuticals Corporation Medical (PDF - 9 MB) Clinical pharmacology (PDF - 1.5MB) Statistical (PDF - 2MB) BPCA Deferasirox - Exjade Novartis Pharmaceuticals Corporation

CDTL Review (PDF - 795 KB)

Medical (PDF - 843 KB)

None None BPCA Deferasirox - Jadenu Novartis Pharmaceuticals Corporation

CDTL Review (PDF - 2MB)

Medical (PDF - 1 MB)

Clinical pharmacology (PDF - 1MB) None BPCA Desoximetasone - Topicort Taro Pharmaceuticals U.S.A., Inc. Medical (PDF - 221 KB) Clinical pharmacology (PDF - 302 KB) None PREA Desvenlafaxine - Pristiq Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.

Medical (PDF - 103 KB)

Medical (PDF - 622 KB)

Clinical pharmacology (PDF - 1.5 MB) Statistical (PDF -  1.5 MB) PREA

Deutetrabenazine - Austedo 

Teva Branded Pharmaceutical Products R&D, Inc. Medical (PDF - 622 KB) None None BPCA Dexlansoprazole - Dexilant Takeda Pharmaceuticals USA Inc. CDTL Review (PDF-661 KB)

Medical (PDF-5 MB)

Clinical pharmacology (PDF-1MB) Statistical (PDF-50KB) PREA Dexmedtomidine hydrochloride - Precedex Hospira Medical (PDF -5MB) Clinical pharmacology (PDF -3.8MB) Statistical (PDF -1MB) BPCA Dexmedetomidine - Precedex Hospira, Inc. CDTL Review (PDF - 3 MB) Clinical pharmacology (PDF -3.8MB) Statistical (PDF - 1MB) PREA Dextroamphetamine - Xelstrym Noven Pharmaceuticals, Inc. Medical (PDF - 1 MB)  None None PREA

Diclofenac epolamine topical system 1.3% - Flector 

IBSA Institut Biochimique SA

Medical (PDF - 1 MB) 

None None PREA Diclofenac potassium - Zipsor 
  Assertio Therapeutics, Inc. Medical (PDF - 2 MB) Clinical pharmacology (PDF - 453 KB) None PREA Difluprednate ophthalmic emulsion - Durezol Alcon Pharmaceuticals Ltd. c/o Alcon Research Ltd Medical (PDF -748 KB) Clinical pharmacology (PDF - 40KB) Statistical (PDF - 479KB) BPCA Dolutegravir and lamivudine - Dovato ViiV Healthcare Company Medical (PDF - 2 MB) None None PREA Dolutegravir - Tivicay ViiV Healthcare Medical (PDF - 8MB) Clinical pharmacology (PDF -11 MB) Statistical (PDF -4MB) PREA Dolutegravir - Tivicay  ViiV Healthcare Medical (PDF - 2 MB)

CDTL Review (PDF - 932 KB)

Clinical pharmacology (PDF -2.2MB) None PREA Dolutegravir - Tivicay PD  ViiV Healthcare Medical (PDF - 241KB) Clinical pharmacology (PDF -89KB) None PREA Doravirine/lamivudine/tenofovir disoproxil fumarate - Delstrigo      Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. CDTL Review (PDF - 962 KB) Clinical pharmacology (PDF - 2 MB) None PREA Doxycycline hyclate delayed-release - Doryx Mayne Pharma International, Pty, Ltd. c/o Warner Chilcott US, LLC Medical (PDF - 241 KB) Clinical pharmacology (PDF - 89 KB) Statistical (PDF - 131 KB) PREA Doxycycline hyclate - LymePak Chartwell Pharma NDA B2 Holdings, LLC Medical (PDF - 1 MB) None None PREA Drospirenone and estetrol tablets - Nextstellis  
  Mayne Pharma LLC Medical (PDF - 3 MB) None None PREA Drospirenone - Slynd Exeltis USA, Inc Medical (PDF - 1 MB) None None PREA Dulaglutide - Trulicity Eli Lilly and Company CDTL (PDF - 1 MB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 2 MB) BOTH Duloxetine - Cymbalta Eli Lilly and Company, Inc. Medical (PDF - 2 MB) Clinical pharmacology (PDF -197KB) Statistical (PDF - 3 MB) PREA Duloxetine - Cymbalta  Eli Lily and Company, Inc. Medical (PDF - 2 MB) None None PREA Duloxetine delayed-release capsules - Drizalma Sprinkle
  Sun Pharma Global FZE Medical (PDF - 2 MB) None None PREA Duloxetine hydrochloride - Cymbalta Eli Lilly and Company Medical (PDF - 8 MB) Clinical pharmacology (PDF - 959 KB) Statistical (PDF -665 KB) BPCA Dupilumab - Dupixent Regeneron Pharmaceuticals, Inc. Medical (PDF - 8 MB) None None PREA Dupilumab - Dupixent Regeneron Pharmaceuticals, Inc. Medical (PDF - 8 MB) None None PREA Dupilumab - Dupixent Regeneron Pharmaceuticals, Inc. Medical (PDF - 5 MB) None None PREA Dupilumab - Dupixent Regeneron Pharmaceuticals, Inc. Medical (PDF - 5 MB) None None PREA Dupilumab - Dupixent Regeneron Pharmaceuticals, Inc. Medical (PDF - 5 MB) None None PREA Econazole nitrate - Ecoza AmDerma Pharmaceuticals, LLC Medical (PDF - 2 MB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 422KB) PREA Edoxaban - Savaysa Daiichi Sankyo, Inc.

CDTL (PDF - 4 MB)

Medical (PDF - 4 MB)

Clinical pharmacology (PDF - 1 MB) None PREA Efavirenz, lamivudine, tenofovir - Symfi Lo  Mylan Pharmaceuticals, Inc. Medical (PDF - 129 KB) Clinical pharmacology (PDF - 1 MB) None PREA Efavirenz, lamivudine, tenofovir Disoproxil Fumarate - Symfi   Mylan Pharmaceuticals, Inc. Medical (541 - KB) None None PREA Efavirenz, Lamivudine and Tenofovir disoproxil fumarate Aurobindo Pharma Limited, India DD Review (PDF - 65 KB) Clinical pharmacology (PDF - 788 KB) None PREA

Efavirenz, lamivudine, tenofovir disoproxil fumarate

 

Macleods Pharmaceuticals Limited, India Medical (PDF - 1.9MB) Clinical pharmacology (PDF - 788 KB) None PREA Efavirenz - Sustiva Bristol-Myers Squibb Company Medical (PDF -1.9MB) Clinical pharmacology (PDF -9.3MB) None BOTH Efinaconazole - Jublia

Bausch Health Americas, Inc.

Medical (PDF - 538 KB) None None PREA

Elbasvir and grazoprevir - Zepatier

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Medical (PDF - 1 MB) Clinical pharmacology (PDF - 1 MB) None PREA Eltrombopag - Alvaiz Teva Pharmaceuticals Inc.

CDTL (PDF - 2 MB)

Medical (PDF - 583 MB)

Clinical pharmacology (PDF - 975 MB) None PREA Eltrombopag - Promacta  Novartis Pharmaceuticals Corporation Medical (PDF - 4 MB) Clinical pharmacology (PDF - 1 MB) Statistical (PDF -1MB) BPCA Eltrombopag - Promacta  Novartis Pharmaceuticals Corporation Medical (PDF - 58 KB) None None  BPCA Eltrombopag - Promacta Novartis Pharmaceuticals Corporation Medical (PDF - 2 MB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 97 KB) BPCA Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - Genvoya Gilead Sciences, Inc. Medical (PDF -13.4MB) Clinical pharmacology (PDF -24.2MB) Statistical (PDF -2.2MB) PREA Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - Genvoya Gilead Sciences, Inc. Medical (PDF - 642 KB) Clinical pharmacology (PDF - 242 KB) None BOTH

Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - Genvoya

Gilead Sciences, Inc. CDTL (PDF - 3 MB) Clinical pharmacology (PDF - 9 MB) None BOTH Elvitegravir, Cobicistat, Emtricitabine/Tenofovir Disoproxil Fumarate - Stribild Gilead Sciences, Inc. CTDL Review (PDF -359KB) Clinical pharmacology (PDF - 462KB) None PREA Empagliflozin - Jardiance Boehringer Ingelheim Pharmaceuticals, Inc. Medical - CDTL (PDF - 7 MB) Clinical pharmacology (PDF - 4 MB) Statistical (PDF - 2 MB) BPCA Empagliflozin and Metformin - Synjardy Boehringer Ingelheim Pharmaceuticals, Inc. CDTL (PDF - 7 MB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 3 MB) BPCA Empagliflozin and Metformin - Synjardy XR Boehringer Ingelheim Pharmaceuticals, Inc. CDTL (PDF - 7 MB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 3 MB) BPCA Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Odefsey Gilead Sciences, Inc. Medical (PDF - 310KB)

CTDL Review (PDF - 578KB)

Clinical pharmacology (PDF - 5MB)

Clinical pharmacology addendum (PDF - 297 KB)

None PREA Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Descovy Gilead Sciences, Inc. Medical (PDF - 1 MB)

Addendum (PDF - 572KB)

Clinical pharmacology (PDF -8 MB) Statistical (PDF -2 MB) PREA Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Descovy Gilead Sciences, Inc. Medical (PDF - 1 MB) Clinical pharmacology (PDF - 8 MB) Statistical (PDF - 2 MB) PREA Emtricitabine and tenofovir alafenamide - Descovy Gilead Sciences, Inc. Medical (PDF - 642 KB) Clinical pharmacology (PDF -145 KB) None PREA Emtricitabine and tenofovir alafenamide - Descovy Gilead Sciences, Inc. CDTL Review (PDF - 2 MB) None None PREA Emtricitabine, Rilpivirine, and Tenofovir isoproxil fumarate - Complera Gilead Sciences, Inc. Medical (PDF - 1MB) Clinical pharmacology (PDF -145 KB) None PREA Emtricitabine and Tenofovir disoproxil fumarate - Truvada  Gilead Sciences, Inc. Medical (PDF - 501KB) Clinical pharmacology (PDF -189KB) None PREA Entecavir - Baraclude Bristol-Myers Squibb Company Medical (PDF - 3 MB) Clinical pharmacology (PDF - 3MB) Statistical (PDF -660 KB) BOTH Entrectinib - Rozlytrek  Genentech Medical (PDF - 23 MB) None None BPCA Entrectinib - Rozlytrek Genentech, Inc. Medical (PDF - 14 MB)  None None BPCA Erlotinib - Tarceva OSI Pharmaceuticals, LLC Medical (PDF - 6 MB) Clinical pharmacology (PDF -2 MB) None BPCA Eribulin mesylate - Halaven Eisai Inc. Medical (PDF - 1 MB) Clinical pharmacology (PDF - 2 MB) None BPCA Epinephrine - Auvi-Q Kaleo, Inc. Medical (PDF - 2 MB) None None PREA Epinephrine - Primatene Mist Armstrong Pharmaceuticals, Inc.

CDTL Review (PDF - 2 MB)

Medical (PDF - 4 MB)

None Statistical (PDF - 660 KB) PREA Escitalopram oxalate - Lexapro Forest Laboratories, Inc. Medical (PDF - 218 KB) None None PREA Escitalopram - Lexapro AbbVie Inc. Medical (PDF - 6 MB) None None PREA Eslicarbazepine acetate - Aptiom Sunovion Pharmaceutical Inc. CDTL Review (PDF - 593 KB)

Medical (PDF - 5 MB)

Clinical pharmacology (PDF - 2.9 KB) None PREA Eszopiclone - Lunesta Sunovion Pharmaceuticals, Inc. Medical (PDF - 1MB) Clinical pharmacology (PDF -883KB) None BOTH Etafilcon - Theravision with Ketotifen Johnson & Johnson Vision Care, Inc.

DD Review (PDF - 2 MB)

Medical (PDF - 460 KB)

None Statistical (PDF - 3 MB) PREA Etanercept - Enbrel Immunex  Corporation, a wholly-owned subsidiary of Amgen Inc.

Medical (PDF - 4.8 MB)

DD Review (PDF - 568 KB)

CDTL Review PDF - 504 KB)

Clinical pharmacology  (PDF - 702 KB) Statistical (PDF - 444 KB) PREA Etanercept - Enbrel  Amgen Inc. Medical (PDF - 4 MB) None None PREA Etanercept-szzs - Erelzi Sandoz Inc. Medical (PDF - 1.7 MB) Clinical pharmacology (PDF - 4.7 MB) Statistical (PDF - 432 KB) PREA Etanercept-szzs - Erelzi
  Sandoz Inc.

CDTL Review PDF - 504 KB)

None None PREA Etanercept-szzs - Erelzi
  Sandoz Inc. Medical (PDF - 2 MB) None None PREA Etravirine - Intelence Janssen Products, LP Medical (PDF -1.4MB) Clinical pharmacology (PDF -1.7MB) None BOTH Etravirine - Intelence Janssen Products, LP Medical (PDF -1 MB) Clinical pharmacology (PDF - 896 KB) None BOTH Everolimus tablets for oral suspension - Afinitor Disperz Novartis Pharmaceuticals Corporation Medical (PDF -10MB) Clinical pharmacology (PDF -2MB) None BPCA Evolocumab - Repatha  Amgen, Inc. Medical (PDF - 5 MB) Clinical pharmacology (PDF - 1 MB) Statistical (PDF - 1 MB) PREA Exenatide - Bydureon AstraZeneca Pharmaceuticals AB C/O AstraZeneca Pharmaceuticals LP Medical (PDF - 3 MB) Clinical pharmacology (PDF - 2 MB) Statistical (PDF - 1 MB) BOTH Exenatide - Byetta AstraZeneca AB Medical (PDF - 802 KB) Clinical pharmacology (PDF - 14 KB) Statistical (PDF - 122 KB) BOTH Fenfluramine HCl - Fintepla
  Zogenix, Inc. Medical (PDF - 588 KB) Clinical pharmacology (PDF - 2 MB) None BPCA Ferric oxyhydroxide - Velphoro Vifor Fresenius Medical Care Renal Pharma France Medical (PDF - 1 MB) None None BPCA Ferric carboxymaltose -Injectafer American Regent, Inc. Medical (PDF - 613 KB) Clinical pharmacology (PDF - 7 MB) None PREA Fesoterodine fumarate - Toviaz  Pfizer, Inc.
  Medical (PDF - 4 MB) Clinical pharmacology (PDF - 6 MB) Statistical (PDF - 300 KB) PREA

Fidaxomicin - Dificid 

Cubist Pharmaceuticals LLC Medical (PDF -3.8MB) None None BPCA Filgrastim-sndz - Zarxio Sandoz, Inc. Medical (PDF -3.8MB)

DD Review  (PDF -86KB)

TL Review (PDF -422KB)

Clinical pharmacology (PDF -2.75MB)

Addendum (PDF - 1.1MB)

Statistical (PDF -6742KB) PREA Filgrastim-aafi - Nivestym  Hospira, Inc.

CDTL Review (PDF - 746 KB)

Medical (PDF - 245 KB)

Clinical pharmacology  (PDF - 661 KB) Statistical (PDF - 377 KB) PREA  Finafloxacin otic suspension - Xtoro Alcon Research, Ltd. Medical (PDF -6.8MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -3.2MB) BOTH Fingolimod - Gilenya  Novartis Pharmaceuticals Corporation

CDTL Review (PDF - 2 MB)

Medical (PDF - 3.8 MB)

Clinical pharmacology (PDF -2MB) Statistical (PDF -3.2MB) BOTH Fingolimod - Tascenso ODT Handa Neuroscience, LLC 
  Medical (PDF - 1 MB) Clinical pharmacology (PDF - 1 MB)  None PREA Fluticasone furoate inhalation powder - Arnuity Ellipta GlaxoSmithKline Medical (PDF -8.6MB) Clinical pharmacology (PDF -5.7MB) Statistical (PDF -1.9) PREA Fluticasone furoate - Arnuity Ellipta GlaxoSmithKline Medical (PDF - 956 KB) Clinical pharmacology (PDF - 2 MB) Statistical (PDF - 507 KB) PREA  Fluticasone furoate - Arnuity Ellipta GlaxoSmithKline Intellectual Property Development Ltd. England Medical (PDF - 956 KB) None None PREA Fluticasone furoate - Flonase Sensimist Allergy Relief Haleon US Holdings Medical (PDF - 489 KB) None Statistical (PDF - 133 KB) PREA Fluticasone Furoate/Umeclidinium/Vilanterol - Trelegy Ellipta GlaxoSmithKline Intellectual Property Development Ltd. England Medical (PDF - 3MB) None None PREA Fluticasone furoate/vilanterol - Breo Ellipta
  GlaxoSmithKline Medical (PDF - 16 MB) Clinical pharmacology (PDF - 5 MB) Statistical (PDF - 4 MB) PREA Fluticasone furoate and vilanterol - Breo Ellipta GlaxoSmithKline Intellectual Property Development Ltd. England C/o GlaxoSmithKline Research & Development Medical (PDF - 6 MB) None None BPCA Fluticasone propionate Lotion - Cutivate Fougera Pharmaceuticals Inc. Medical (PDF -1.2MB) Clinical pharmacology (PDF -1.4MB) None PREA Fluticasone propionate/salmeterol xinafoate - Advair HFA GlaxoSmithKline Medical (PDF -1 MB) Clinical pharmacology (PDF -267KB) Statistical (PDF -52 KB) PREA Fluticasone propionate - ArmonAir RespiClick Teva Pharmaceutical Industries Ltd. Medical (PDF -10 MB) Clinical pharmacology (PDF - 4.3MB) Statistical (PDF -1.2 KB) PREA

Fluticasone propionate - ArmonAir RespiClick

Teva Pharmaceutical Industries Ltd. c/o: Teva Branded Pharmaceutical Products R&D Inc. Medical (PDF - 6 MB) None None BOTH Fluticasone propionate/salmeterol - AirDuo Teva Pharmaceutical Industries Ltd. Medical (PDF -10 MB) Clinical pharmacology (PDF - 4.3 MB) Statistical (PDF -1.2 KB) PREA

Formoterol fumarate and mometasone furoate - Dulera

Merck Sharp & Dohme Corp. Medical (PDF - 10 MB) None None BOTH Fosaprepitant - Emend   Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Medical (PDF - 2 MB) Clinical pharmacology (PDF -  7 MB) Statistical (PDF - 662 KB) BOTH Fosaprepitant - Focinvez
  Spes Pharmaceuticals Inc.
 

Unireview (PDF - 248 MB)

Unireview (PDF - 1 MB)

None None PREA Fosphenytoin sodium - Cerebyx Parke-Davis, a Division of Pfizer, Inc. CDTL Review (PDF - 390 KB)

Medical (PDF - 1.5 MB)

Clinical pharmacology (PDF - 5 MB) None BPCA Gadobutrol - Gadavist Bayer HealthCare Pharmaceuticals, Inc. Medical (PDF - 958KB) Clinical pharmacology (PDF -2.2MB) Statistical (PDF -422 KB) PREA Gadobutrol - Gadavist Bayer Healthcare Pharmaceuticals, Inc. Medical (PDF - 7MB) None Statistical (PDF -782 KB) PREA

Gadopiclenol - Elucirem

Guerbet LLC Medical (PDF - 3 MB) None None PREA Gadoterate meglumine - Dotarem Guerbet LLC Medical (PDF - 3MB) Clinical pharmacology (PDF -768KB) Statistical (PDF -1.2 MB) PREA Gadoterate meglumine - Dotarem Guerbet LLC Medical (PDF 1.3 MB) Clinical pharmacology (PDF - 1.5 MB) Statistical (PDF - 398 KB) PREA Gadoteridol - ProHance Bracco Diagnostics, Inc Medical (PDF - 3 MB) None None PREA Gadoxetate disodium - Eovist  Bayer HealthCare Pharmaceuticals, Inc. Medical (PDF -1.2MB) Clinical pharmacology (PDF -1.5MB) None PREA Gatifloxacin ophthalmic solution - Zymar Allergan, Inc. Medical (PDF - 78 KB) None None BPCA Gatifloxacin - Zymar   Allergan, Inc. DDTL (PDF - 428 KB) None None Both

Gepirone - Exxua

Fabre-Kramer Pharmaceuticals, Inc. Medical (PDF - 10 MB) None None Both Glecaprevir and Pibrentasvir - Mavyret  AbbVie Inc.

CTDL (PDF - 2 MB)

CTDL Addendum (PDF - 187 KB)

Clinical pharmacology (PDF - 409 KB) Statistical (PDF - 439 KB) PREA Glecaprevir and Pibrentasvir - Mavyret  AbbVie Inc. Medical (PDF - 78 KB) None None PREA Glecaprevir and pibrentasvir - Mavyret   AbbVie, Inc. Medical (PDF - 2 MB) Clinical pharmacology (PDF - 3 MB) None BOTH Glucagon - Gvoke  Xeris Pharmaceuticals, Inc. Medical (PDF - 3 MB)

CTDL Review (PDF - 3 MB

Clinical pharmacology (PDF - 2 MB) Statistical (PDF - 2 MB) PREA Glucagon - Baqsimi   Eli Lilly and Company
  Medical (PDF - 3 MB)

CTDL Review (PDF - 3 MB

Clinical pharmacology (PDF - 2 MB) Statistical (PDF - 2 MB) PREA Glycopyrronium - Qbrexza Dermira, Inc. Medical (PDF -  6 MB)   None None

PREA

 

Golimumab - Simponi Janssen Biotech, Inc.

Medical (PDF - 3.1 MB)
 

Clinical pharmacology (PDF - 307 KB) Statistical (PDF - 1.1 MB) PREA Golimumab - Simponi Aria  Janssen Biotech, Inc. Medical (PDF -  4 MB) None None PREA Guanfacine - Intuniv Shire Medical (PDF - 2 MB)

CTDL Review (PDF -134 KB)

Clinical pharmacology (PDF - 330 KB) Statistical (PDF - 544 KB) Both Guanfacine - Intuniv Shire Medical (PDF -3MB) Clinical pharmacology (PDF - 667KB) Statistical (PDF -3MB) PREA Halobetasol - Propionate Ultravate Sun Pharmaceutical Industries, Inc. Medical (PDF - 150 KB) Clinical pharmacology (PDF - 303 KB) None PREA

Halobetasol Propionate - Lexette 

Mayne Pharma LLC Medical (PDF - 249 KB) Clinical pharmacology (PDF - 752 KB) None BOTH Ibrexafungerp - Brexafemme  SCYNEXIS, Inc. Medical (PDF - 10 MB) None None PREA Ibrexafungerp - Brexafemme  SCYNEXIS, Inc. Medical (PDF - 1 MB) None None PREA Ibrutinib - Imbruvica Pharmacyclics LLC
  Medical (PDF - 20 MB) None None BPCA Ibuprofen - Caldolor  Cumberland Pharmaceuticals, Inc. CTDL Review (PDF -134 KB) Clinical pharmacology (PDF - 752 KB) None PREA Ibuprofen - Caldolor Cumberland Pharmaceuticals, Inc. DD Summary Review (PDF -669KB)

Medical (PDF -3MB)
 

Clinical pharmacology (PDF -3.7MB) Statistical (PDF -378KB) PREA IncobotulinumtoxinA - Xeomin  Merz Pharmaceuticals GmbH Medical (PDF - 2 MB) None Statistical (PDF - 1 MB) PREA incobotulinumtoxinA - Xeomin Merz Pharmaceuticals GmbH Medical (PDF - 1 MB) None Statistical (PDF - 872 KB) PREA

Indocyanine green for Injection - Spy Agent Green

 

Novadaq Technologies ULC Medical (PDF - 4 MB)  None None PREA Infliximab-axxq - Avsola Amgen, Inc. Medical (PDF - 4 MB)  None None PREA Infliximab-dyyb - Inflectra Celltrion, Inc. Medical (PDF -5.3MB)

Addendum (PDF - 1MB)

None Statistical (PDF -2MB) PREA Infliximab-abda - Renflexis Samsung Bioepsis Co., Ltd

CDTL Review (PDF - 1 MB)

Medical (PDF - 3.5 MB)

Medical 2(PDF - 267 KB)

Medical 3 (PDF - 93 KB)

Clinical pharmacology (PDF - 7.7 MB)

Statistical (PDF - 959 KB)

Statistical 2 (PDF - 602 KB)

PREA Insulin aspart injection - Fiasp Novo Nordisk Inc.

CDTL Review (PDF - 1 MB)

Medical (PDF - 3.5 MB)

Clinical pharmacology (PDF -  4MB) Statistical (PDF - 905KB) PREA Insulin Degludec - Tresiba Novo Nordisk Inc. CDTL Review (PDF -  7MB)

Medical (PDF - 7 MB)

Clinical pharmacology (PDF -  4MB) Statistical (PDF - 905KB) PREA Insulin Degludec / Insulin Aspart) - Ryzodeg Novo Nordisk Inc. Medical (PDF - 7 MB) Clinical pharmacology (PDF -  4 MB) Statistical (PDF - 905 KB) PREA

Insulin glargine-yfgn - Semglee

Mylan Pharmaceuticals Inc. Medical (PDF - 8 MB) None None PREA Insulin glargine-aglr - Rezvoglar Eli Lilly and Company Medical (PDF - 2 MB) None None PREA Insulin lispro-aabc - Lyumjev
  Eli Lilly and Company Medical (PDF - 1 MB)

Clinical pharmacology (PDF - 10 MB)

Clinical pharmacology
addendum (PDF - 10 KB)

Statistical (PDF - 253 KB) PREA Iodixanol - Visipaque

GE HealthCare Inc.

CDTL Review (PDF - 2 MB)

Medical (PDF - 2 MB)

Clinical pharmacology (PDF -  988 KB) Statistical (PDF - 1.8 MB) PREA Iohexol - Oraltag Interpharma Praha, a.s. Medical (PDF - 91 KB) Clinical pharmacology (PDF - 294 KB) Statistical (PDF - 98 KB) PREA Ipilimumab - Yervoy  Bristol-Myers Squibb Company Medical (PDF  6 MB) Clinical pharmacology (PDF - 1.6 MB) None BPCA Iron Sucrose Injection, USP - Venofer Luitpold Pharmaceuticals, Inc. Medical (PDF - 2 MB) Clinical pharmacology (PDF - 114 KB) Statistical (PDF - 576 KB) PREA Isavuconazonium sulfate - Cresemba Astellas Pharma US Inc. Medical (PDF - 5 MB) None None BPCA Ivabradine - Corlanor  Amgen Inc.

CDTL (PDF - 3 MB)

Medical (PDF - 4 MB)

Clinical pharmacology (PDF - 4 MB) Statistical (PDF - 51 KB) BPCA Ivacaftor - Kalydeco Vertex Pharmaceuticals Incorporated Medical (PDF - 4 MB) None None BPCA Ixekizumab - Taltz Eli Lilly and Company Medical (PDF - 2 MB) None None PREA Kit for the preparation of technetium Tc 99m-labeled carbon inhalation aerosol - Technegas Cyclomedica Australia Pty Ltd. Medical (PDF - 1 MB) None None PREA Kit for the Preparation of Technetium Tc 99m Pentetate Injection - Draximage  Jubilant DraxImage, Inc
  Medical (PDF - 2 MB) None Statistical (PDF - 1 MB) PREA Lacosamide - Motpoly XR Aucta Pharmaceuticals, Inc. Medical (PDF - 276 KB) Clinical pharmacology (PDF - 1 MB) None PREA Lacosamide - Vimpat  UCB, Inc.

CDTL Review (PDF - 371 KB)

Medical (PDF - 915 KB)

Clinical pharmacology (PDF - 2 MB) None

PREA

Lacosamide - Vimpat  UCB, Inc.

Medical (PDF - 541 KB)

Medical (PDF - 631 KB)

Clinical pharmacology (PDF - 1 MB) Statistical (PDF - 2 MB) PREA Lacosamide - Vimpat  UCB, Inc. Medical (PDF - 700 KB) Clinical pharmacology (PDF - 800 KB) None PREA Lacosamide - Vimpat UCB, Inc. Medical (PDF - 2 MB) Clinical pharmacology (PDF - 1 MB) Statistical (PDF - 9 MB) PREA Lactic acid citric acid and K bitartrate - Phexxi Evofem, Inc. Medical (PDF - 1 MB) Clinical pharmacology (PDF - 1 KB) Statistical (PDF - 3 76706 KB) PREA Lamivudine - Epivir ViiV Healthcare Company Medical (PDF -4.2 MB) Clinical pharmacology (PDF - 3 MB)   PREA Lamivudine and Raltegravir - Dutrebis Merck Sharp & Dohme Corp. Medical (PDF -1 MB) Clinical pharmacology (PDF - 6.4 MB) None PREA Lamivudine and tenofovir - Cimduo  Mylan Pharmaceuticals India Medical (PDF - 73 KMB) Clinical pharmacology (PDF -  1 MB) None PREA

Lamivudine and tenofovir disoproxil fumarate - Temixys

 

Celltrion, Inc.

Medical (PDF -  20 KB) 

Clinical pharmacology addendum (PDF -  166 KB)

Clinical pharmacology (PDF -  1 MB)
  

None   PREA Lamotrigine - Lamictal  GlaxoSmithKline LLC Medical (PDF -18 MB) Clinical pharmacology (PDF - 793 KB) Statistical (PDF - 1.8 MB) PREA Lanadelumab-flyo - Takhzyro  Takeda Pharmaceuticals U.S.A., Inc. Medical (PDF - 7 MB) None None BPCA Ledipasvir-sofosbuvir - Harvoni Gilead Sciences, Inc. Medical and CDTL (PDF - 1.5 MB) Clinical pharmacology (PDF - 539 KB) Statistical (PDF - 205 KB)  PREA Ledipasvir-sofosbuvir - Harvoni Gilead Sciences, Inc. Medical (PDF - 426 KB) None None BOTH Leuprolide acetate - Fensolvi Tolmar, Inc. Medical (PDF - 280 KB) Clinical pharmacology (PDF - 4 MB Statistical (PDF - 2 MB) PREA Levalbuterol hydrochloride - Xopenex Oak Pharmaceuticals Medical (PDF - 8 MB) Clinical pharmacology (PDF - 4 MB) Statistical (PDF - 2 MB) PREA Levalbuterol tartrate - Xopenex HFA Sunovion Pharmaceuticals Inc. Medical (PDF - 4 MB) Clinical pharmacology (PDF - 1 MB) Statistical (PDF 1 MB) PREA Levamlodipine - Conjupri CSPC Ouyi Pharmaceutical Co., Ltd. Medical (PDF - 2 MB) Clinical pharmacology (PDF - 569 KB) None PREA Levetiracetam - Keppra Extended Release Tablets UCB, Inc. DD Summary Review (PDF - 202 KB)

CDTL Review (PDF - 371 KB)

Medical (PDF - 327 KB)

Clinical pharmacology (PDF - 1 MB) None PREA Levomilnacipran - Fetzima AbbVie Inc. Medical (PDF - 4 MB) None None PREA Levonorgestrel - Liletta Medicines360 Medical (PDF - 9 MB) Clinical pharmacology (PDF - 1 MB)

Clinical pharmacology (PDF - 2 MB)

Statistical (PDF - 2 MB) PREA Levonorgestrel/ethinyl estradiol tablets  Exeltis

CDTL (PDF - 9 MB)

Medical (PDF - 9 MB)

Medical (PDF - 9 MB)

Clinical pharmacology (PDF - 1 MB)

Clinical pharmacology (PDF - 4 MB)

Statistical (PDF - 1.5 MB) PREA Levonorgestrel/ethinyl estradiol and ethinyl estradiol - Quartette Teva Branded Pharmaceutical Products R&D, Inc. Medical (PDF - 5 MB) Clinical pharmacology (PDF - 4 MB)

Clinical pharmacology addendum (PDF - 89KB)

Statistical (PDF - 1MB) PREA Levonorgestrel-releasing intrauterine system - Skyla Bayer HealthCare Pharmaceuticals, Inc. Medical (PDF - 8MB) Clinical pharmacology (PDF - 4MB) Statistical (PDF - 424 KB) PREA

Levonorgestrel releasing intrauterine system - Liletta

Medicines360

CDTL Review (PDF - 179KB)

Medical (PDF - 2 MB)

Clinical pharmacology (PDF - 1 MB) Statistical (PDF - 168 KB) PREA

Levonorgestrel - Mirena

Bayer HealthCare Pharmaceuticals, Inc. Medical (PDF - 2 MB) None None PREA Levothyroxine sodium oral solution - Tirosint-SOL Cromsource, Inc.

CDTL Review (PDF - 461 KB)

Medical (PDF - 3 MB)

Clinical pharmacology (PDF - 2 MB) None PREA Linaclotide - Linzess AbbVie Inc. Medical (PDF - 3 MB) None None BOTH Linagliptin and Metformin Hydrochloride - Jentadueto XR Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF - 7 MB) Clinical pharmacology (PDF - 1 MB) Statistical (PDF - 246 KB) BOTH Linagliptin and Metformin hydrochloride - Tradjenta Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF - 7 MB) Clinical pharmacology (PDF - 1 MB) Statistical (PDF -  246 KB) BOTH Linagliptin - Tradjenta Boehringer Ingelheim Pharmaceuticals, Inc Medical (PDF - 7 MB) Clinical pharmacology (PDF - 2 MB) Statistical (PDF - 2 MB) BOTH Lipid injectable emulsion - SMOFlipid  Fresenius Kabi USA, LLC Medical (PDF - 3 MB) Clinical pharmacology (PDF - 2 MB) None PREA

Liraglutide - Saxenda

Novo Nordisk, Inc. Medical (PDF - 5 MB) Clinical pharmacology (PDF - 5 MB) Statistical (PDF - 2 MB) PREA Liraglutide - Victoza Novo Nordisk Inc. Medical (PDF - 8 MB) Clinical pharmacology (PDF - 864 KB) Statistical (PDF - 450 KB) BOTH Lisdexamfetamine dimesylate - Vyvanse  Shire Development, LLC Medical (PDF - 218 KB) Clinical pharmacology (PDF - 1 MB) None BOTH Lisdexamfetamine mesylate - Vyvanse Shire Medical (PDF - 2 MB) None Statistical (PDF - 1 MB) PREA

Lisdexamfetamine dimesylate - Vyvanse

 

Takeda Pharmaceuticals U.S.A., Inc. Medical (PDF - 804 KB) None None BOTH Lisenatide - Adlyxin 
  Sanofi-aventis U.S. LLC Medical (PDF - 182 KB) Clinical pharmacology (PDF - 1 MB) None BOTH Lumacaftor and ivacaftor - Orkambi
  Vertex Pharmaceuticals Incorporated Medical (PDF - 6 MB) None None BPCA Loteprednol -  Lotemax  Bausch & Lonb Inc.

Medical (PDF -  318 KB)

Medical (PDF -  218 KB)

None Statistical (PDF - 3 MB) PREA Luliconazole - LuzuTM Medicis Pharmaceutical Corporation, a division of Valeant Pharmaceuticals NA LLC

CDTL (PDF - 358 KB) 

CDTL  (PDF - 372 KB) 

Medical (PDF - 306 KB)

Medical (PDF - 616 KB)

Clinical pharmacology (PDF -1 MB) 

Clinical pharmacology (PDF - 423 KB)

Statistical (PDF - 207 KB)  PREA Lopinavir / Ritonavir - Kaletra AbbVie Inc. Medical (PDF - 5.8 MB) Clinical pharmacology (PDF -2.3 MB) Statistical (PDF - 2 MB) PREA Lubiprostone - Amitizia Sucampo Pharmaceuticals Inc. Medical (PDF - 11 MB) Clinical pharmacology (PDF - 1 MB) Statistical (PDF - 1 MB) PREA Lutetium Lu177 dotatate - Lutathera Advanced Accelerator Applications USA, Inc. Medical (PDF - 3 MB) None None BPCA Lurasidone hydrochloride - Latuda Sunovion Pharmaceuticals, Inc.

Medical (PDF - 6 MB)

Medical (PDF - 7 MB)

Clinical pharmacology (PDF - 3 MB)

Statistical (PDF - 369 KB)

Statistical (PDF - 255 KB)

BOTH Lurasidone hydrochloride - Latuda Sunovion Pharmaceuticals, Inc.

CDTL (PDF - 6 MB)

Medical (PDF - 6 MB)

Clinical pharmacology (PDF - 2 MB) Statistical (PDF - 368 KB) PREA Lurasidone hydrochloride - Latuda Sunovion Pharmaceuticals, Inc. Medical (PDF - 1 MB) None None PREA Maraviroc - Selzentry Viiv Healthcare Medical (PDF - 1 MB) Clinical pharmacology (PDF - 3 MB) None PREA Maraviroc - Selzentry Viiv Healthcare Medical (PDF - 1 MB) Clinical pharmacology (PDF - 3 MB) None BPCA Memantine hydrochloride - Namenda XR Forest Research Institute, Inc. (subsidiary of Forest Laboratories Inc.) Medical (PDF - 2 MB) Clinical pharmacology (PDF - 956 KB) Statistical (PDF - 1 MB) BPCA Mepolizumab - Nucala GlaxoSmithKline LLC Medical (PDF - 8 MB) Clinical pharmacology (PDF - 6 MB)

Clinical pharmacology addendum (PDF - 425 KB)

Statistical (PDF - 1 MB) PREA Mepolizumab - Nucala GlaxoSmithKline LLC Medical(PDF - 8 MB) None None PREA Mepolizumab - Nucala GlaxoSmithKline LLC Medical (PDF - 8 MB) None None PREA Mirabegron - Myrbetriq   Astellas Pharma Global Development, Inc. Medical (PDF - 13 MB)

Clinical pharmacology (PDF - 3 MB)

Statistical (PDF - 168KB) BOTH Mesalamine - Asacol HD Warner Chilcott Medical (PDF - 6 MB) Clinical pharmacology (PDF - 3 MB)

Clinical pharmacology (PDF - 518 KB)

Statistical (PDF -499 KB) PREA Mesalamine  - Canasa Forest Laboratories Medical (PDF - 6 MB) Clinical pharmacology (PDF - 251 KB) Statistical (PDF - 344 KB) PREA Mesalamine - Delzicol Warner Chilcott LLC Medical (PDF - 707 KB)

Medical Addendum(PDF - 495 KB)

Clinical pharmacology (PDF - 116 KB) None PREA Mesalamine - Delzicol  Warner Chilcott (US), LLC Medical (PDF - 5 MB) Clinical pharmacology (PDF - 729 KB) Statistical (PDF - 1 KB) PREA Mesalamine - Lialda  Shire Development, LLC Medical (PDF - 6 MB) None None PREA

Metformin hydrochloride for extended-release oral suspension - Riomet ER

Pharmaceutical Industries Limited CTDL Review (PDF - 917 KB) Clinical pharmacology (PDF - 818 KB) None PREA 10% Methyl salicylate, 3% L-menthol - Salonpas Pain Relief  Hisamitsu Pharmaceutical Co., Inc. Medical (PDF - 998 KB)

Medical (PDF - 3 MB)

Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 1 MB) PREA

Methylphenidate hydrochloride extended-release - Aptensio XR

Rhodes Pharmaceuticals L.P. Medical (PDF - 2 MB) Clinical pharmacology (PDF - 4 MB) Statistical (PDF - 1 MB)
Statistical (PDF - 629 KB) PREA Methylphenidate hydrochloride - Aptensio XR Rhodes Pharmaceuticals L.P. CTDL Review (PDF - 592 KB)

Medical (PDF - 3 MB)

Clinical pharmacology (PDF - 2 MB) 

Statistical (PDF - 1 MB)

Statistical (PDF - 139 KB) 

BOTH Methylphenidate hydrochloride - Quillivant XR NextWave Pharmaceuticals, Inc. Medical (PDF - 26 KB) Clinical pharmacology (PDF - 588 KB) Statistical (PDF - 380 KB) PREA Methylphenidate hydrochloride extended release chewable tablets - QuilliChew ER  Pfizer Inc. CTDL Review (PDF -1 MB)

Medical (PDF - 5 MB)

Clinical pharmacology (PDF -2.9MB) Statistical (PDF -498KB) PREA

Methylphenidate HCL extended-release capsules - Adhansia XR 

Purdue Pharma 

Medical (PDF - 2 MB)

Medical (PDF - 5 MB)

Clinical pharmacology (PDF - 2 MB) 

Statistical (PDF - 1 MB)

Statistical (PDF - 2 MB) 

PREA

Methylphenidate hydrochloride - Jornay PM

 

Ironshore Pharmaceuticals & Development, Inc. Medical (PDF - 4.8 MB) Clinical pharmacology (PDF - 2.1 MB) Statistical (PDF - 921 KB) PREA Methylphenidate extended-release orally disintegrating tablets - Cotempla XR-ODT  Neos Therapeutics, Inc.

Medical (PDF - 5.7 MB)

Medical (PDF - 1.2 MB)

Clinical pharmacology (PDF - 2.1 MB)

Clinical pharmacology (PDF - 2.1 MB)

Statistical (PDF - 921 KB)

Statistical (PDF - 96 KB)

PREA Methoxy polyethylene glycol-epoetin beta - Mircera Vifor International AG

Medical (PDF - 2.3 MB)

None

Statistical (PDF - 239 KB)

PREA Methoxy polyethylene glycol-epoetin beta - Mircera Vifor (International) AG c/o ProPharma Group Medical (PDF - 7 MB) Clinical Pharmacology (PDF - 5MB) Statistical (PDF - 7 MB) PREA Metoprolol Succinate - KAPSPARGO SPRINKLE Sun Sun Pharmaceutical Industries LimitedPharmaceutical Industries Limited Medical (PDF - 799 KB) Clinical pharmacology (PDF - 978 KB) None PREA Metronidazole - Likmez Saptalis Pharmaceuticals, LLC Medical (PDF - 6 MB) None None PREA Metronidazole vaginal gel 1.3% - Nuvessa Chemo Research SL Medical (PDF - 1 MB) Clinical pharmacology (PDF - 70 KB) Statistical (PDF - 127 KB) PREA  Micafungin for injection - Mycamine Astellas Pharma US, Inc. Medical (PDF - 1 MB) None None BOTH

Micafungin in Sodium Chloride Injection - Micafungi

Baxter HealthCare Corporation Medical (PDF - 1 MB) None None PREA Micafungin sodium - Mycamine Astellas Pharma US, Inc. Medical (PDF - 2 MB)

Clinical pharmacology (PDF - 4.4MB)

Statistical (PDF -987KB) BPCA Minocycline - Amzeeq
  Foamix Pharmaceuticals Inc. Medical (PDF - 2.2 MB) None None PREA Mirabegron extended-release tablets and mirabegron extended-release for oral suspension - Myrbetriq and Myrbetriq Granules Astellas Pharma Global Development, Inc. Medical (PDF - 13 MB) None None BOTH Mixed salts of a single-entity amphetamine product - Mydayis  Shire Development, LLC.

Medical (PDF - 7 MB)

Clinical pharmacology  (PDF -1.8KB) Statistical (PDF -987KB) PREA Mixed salts of a single entity amphetamine product - Mydayis  Shire Development, LLC. Medical (PDF - 7 MB) None None BPCA Mometasone furoate - Asmanex HFA Merck Sharp & Dohme Corp. Medical (PDF - 3 MB) Clinical pharmacology (PDF -2 MB) Statistical (PDF -603KB) PREA Mometasone furoate - Asmanex HFA Merck Sharp & Dohm Corp Medical (PDF- 1 MB) None None PREA Mometasone furoate - Asmanex HFA Merck Sharp & Dohm Corp Medical (PDF - 1 MB) None None PREA Mometasone furoate and formoterol fumarate - Dulera Schering-Plough Medical (PDF- 1 MB) None None PREA Morphine sulfate - Morphine sulfate Hospira, Inc. Medical (PDF - 1 MB) None None PREA Morphine sulfate - Morphine sulfate Hikma Pharmaceuticals USA Inc. Medical (PDF - 5 MB) Clinical pharmacology (PDF - 3 MB) None PREA

Moxifloxacin - Avelox

Bayer Pharmaceuticals Medical (PDF- 905 KB) Clinical pharmacology (PDF - 2 MB) Statistical (PDF - 760 KB) PREA Moxifloxacin ophthalmic solution - Vigamox Alcon Pharmaceuticals, Ltd. Medical (PDF - 434 KB)

DD Summary Review (PDF- 118 KB)

None None BPCA Mycophenolate mofetil - CellCept
  Roche Palo Alto LLC Medical (PDF - 6 MB) None None PREA Naftifine hydrochloride - Naftin Merz Pharmaceuticals, LLC Medical (PDF - 488 KB) Clinical pharmacology (PDF - 1 MB) Statistical (PDF - 188 KB) PREA Naftifine hydrochloride - Naftin Cream, 2% Merz Pharmaceuticals, LLC Medical (PDF - 1 MB) Clinical pharmacology (PDF - 2 MB) Statistical (PDF - 822 KB)  PREA Nalmefene - Opvee Opiant Pharmaceuticals, Inc.

CTDL Review (PDF - 4 MB)

Clinical pharmacology (PDF - 9 MB)

Clinical pharmacology addendum (PDF - 9 KB)

Statistical (PDF - 2 MB) PREA Naloxone hydrochloride - Kloxxado 

 

Hikma Pharmaceuticals USA, Inc.

CTDL Review (PDF - 613 KB)

CTDL and DD Review (PDF - 1 MB)

Medical (PDF - 4 MB)

None None PREA Naloxone hydrochloride - Narcan Nasal Spray  Adapt Pharma Operations Limited DD Summary Review(PDF -1 MB)

CTDL Review (PDF - 3 MB)

Clinical pharmacology (PDF - 2 MB) None PREA Naloxone Hydrochloride Injection - Naloxone Hydrochloride Injection Kaleo, Inc. CDTL Review (PDF - 2 MB) Clinical pharmacology (PDF - 4 MB) None PREA Naloxone Hydrochloride - Rextovy Amphastar Pharmaceuticals, Inc

Medical (PDF - 3 MB)

CDDD Review (PDF - 637 KB)

Clinical pharmacology (PDF - 2 MB) None PREA Naloxone Hydrochloride - Rezenopy Summit Biosciences

Medical (PDF - 2MB)

CDTL Review (PDF - 3MB)

Clinical pharmacology (PDF - 1MB) None PREA Naloxone hydrochloride - RiVive Harm Reduction Therapeutics, Inc. Medical (PDF - 2 MB) None None PREA

Naloxone hydrochloride - Zimhi

Adamis Pharmaceuticals Corporation CDTL Review (PDF - 2 MB) Clinical pharmacology (PDF - 368 KB) None PREA Naproxen sodium 220 mg and Diphenhydramine hydrochloride - Aleve PM Bayer HealthCare, LLC – Consumer Care Medical (PDF - 1 MB) Clinical pharmacology (PDF - 2 MB) Statistical (PDF -1 MB) PREA Naproxen and esomeprazole magnesium - Vimovo  Horizon Pharma Inc. Medical (PDF - 4 MB) Clinical pharmacology (PDF - 2 MB) None PREA Neostigmine methylsulfate - Bloxiverz Eclat Pharmaceuticals, LLC Medical (PDF - 8 MB) Clinical pharmacology (PDF - 2 MB) None PREA Neostigmine methylsulfate and glycopyrrolate - Prevduo Slayback Pharma LLC CDTL Review (PDF - 794 KB) Clinical pharmacology (PDF - 284 KB) None PREA Nevirapine - Viramune XR Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF -2MB) Clinical pharmacology (PDF - 446 KB) Statistical (PDF - 723KB) PREA Nilotinib -  Tasigna   Sponsor: Novartis Pharmaceuticals Corporation Medical (PDF - 1 MB) Clinical pharmacology (PDF - 1.6 MB) Statistical (PDF - 124 KB) BPCA Nintedanib - Ofev Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF - 10 MB) None None BPCA Nirmatrelvir - Ritonavir - Paxlovid Pfizer, Inc Medical (PDF - 27 MB) None None PREA Nirsevimab-alip - Beyfortus AstraZeneca AB Medical (PDF - 20 MB) None None PREA Nitisinone - NITYR Cycle Pharmaceuticals Ltd. Medical (PDF - 358 KB) Clinical pharmacology (PDF - 4 MB) None PREA Nitisinone - NITYR Cycle Pharmaceuticals Ltd. Medical (PDF - 358 KB) None None PREA Nivolumab - Opdivo 
  Bristol-Myers Squibb Company
 

DD (PDF - 188 KB)

Medical (PDF - 222 KB)

Clinical pharmacology (PDF - 202 KB)

Clinical pharmacology  (PDF - 250 KB)

Noen PREA Nivolumab - Opdivo Bristol-Myers Squibb Company Medical (PDF - 8 MB) None None BPCA Nivolumab - Opdivo Bristol-Myers Squibb Company Medical (PDF - 11 MB) None None BPCA

Nivolumab and relatlimab-rmbw - Opdualag

Bristol-Myers Squibb Company Medical (PDF - 29 MB) None None PREA Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules - Taytulla  Warner Chilcott Company, LLC Medical (PDF -1MB) Clinical pharmacology (PDF -3.2MB) Statistical (PDF - 469 KB) PREA Obiltoxaximab - Anthim Elusys Theraputics, Inc. Medical (PDF -18 MB)

Addendum (PDF - 249 KB)

Clinical pharmacology (PDF -12MB)

Addendum (PDF -126 KB)

Statistical (PDF - 9 MB) PREA Ocriplasmin- Jetrea ThromboGenics, Inc. Medical (PDF - 817 KB) Clinical pharmacology (PDF - 117KB) Statistical (PDF - 760 KB)  PREA Olanzapine and fluoxetine hydrochloride - Symbyax Eli Lilly and Company Medical (PDF - 1 MB) Clinical pharmacology (PDF -1.2MB)

Addendum (PDF - 132KB)

Statistical (PDF - 953 KB) PREA Olopatadine - Pazeo Alcon Research LTD Medical (PDF - 2 MB) Clinical pharmacology (PDF -340KB) Statistical (PDF - 4 KB) BOTH Olopatadine hydrochloride and mometasone furoate - Ryaltris Glenmark Specialty SA

Medical (PDF - 6 MB)

CDTL (PDF - 6 MB)

None None PREA Omalizumab - Xolair Genentech Medical (PDF - 6 MB) Clinical pharmacology (PDF -1.3MB) Statistical (PDF - 2MB) PREA Omalizumab - Xolair Genentech, Inc. and Novartis Pharmaceuticals Corp. Medical (PDF- 4 MB) Clinical pharmacology (PDF -1MB) Statistical (PDF - 1 MB)  PREA

Omalizumab - Xolair

 

Genentech, Inc. and Novartis Pharmaceuticals Corp. Medical (PDF - 5 MB) None None  PREA Omalizumab - Xolair Genentech, Inc. Medical (PDF - 8 MB) None None PREA Omeprazole magnesium - Prilosec  AstraZeneca Pharmaceuticals LP Medical (PDF - 908 KB) Clinical pharmacology (PDF - 2 MB) None PREA

OnabotulinumtoxinA - Botox

Allergan, Inc.

CDTL (PDF - 403 KB)
 

Medical (PDF - 1 MB)

None Statistical (PDF - 173 KB) PREA  OnabotulinumtoxinA - Botox Allergen, Inc

Medical (PDF - 3 MB)
 

Medical (PDF - 1 MB)

None Statistical (PDF - 1 MB) PREA OnabotulinumtoxinA - Botox  Allergen, Inc Medical (PDF - 1 MB) None None PREA OnabotulinumtoxinA - Botox
  Allergan, Inc. Medical (PDF - 1 MB) None Statistical (PDF - 2 MB) PREA OnabotulinumtoxinA - Botox
  Allergan, Inc. Medical (PDF - 3 MB) None None PREA Oxaprozin - Coxanto Solubiomix, Inc. Medical (PDF - 3 MB) Clinical pharmacology (PDF - 2 MB) None PREA Oxcarbazepine - Oxtellar XR Supernus Pharmaceuticals, Inc. Medical (PDF - 5 MB) Clinical pharmacology (PDF - 7 MB) Statistical (PDF - 482 KB) PREA Oxycodone hydrochloride - Oxycodone hydrochloride Genus Lifesciences, Inc.

Medical (PDF - 2 MB)

DD Memo (PDF - 1 MB)

Clinical pharmacology (PDF - 688 KB) None PREA Oxycodone hydrochloride - Oxycontin Purdue Pharma L.P. Medical (PDF - 17 MB) Clinical pharmacology (PDF - 2 MB) Statistical (PDF - 678 KB) BPCA Oxymorphone - Opana   Medical (PDF - 17 MB) Clinical pharmacology (PDF - 2 MB) None PREA Ozenoxacin - Xepi  Ferrer Internacional S.A. Medical (PDF - 2 MB) Clinical pharmacology (PDF - 1 MB) Statistical (PDF - 524 KB) PREA Paclitaxel - Abraxane Abraxis BioScience, L.L.C., a wholly-owned subsidiary of Celgene Corporation Medical (PDF - 235 KB) None None BPCA Palifermin - Kepivance Quintiles, Inc. Medical (PDF - 280 KB) Clinical pharmacology (PDF - 726 KB) None PREA Palonosetron hydrochloride - Aloxi Helsinn Healthcare SA Medical (PDF - 15 MB)

Medical (PDF - 2 MB)

Clinical pharmacology (PDF -2 MB) Statistical (PDF - 771 KB) BOTH Pancrelipase - Creon AbbVie Inc. Medical (PDF - 566 KB) None None PREA Pancrelipase - Pancreaze  Janssen Pharmaceuticals, Inc. Medical (PDF - 142 KB) None None PREA Pancrelipase - Pertzye Digestive Care, Inc. Medical (PDF - 1 MB) None None PREA Pancrelipase - Zenpep Aptalis Pharma Limited. Medical (PDF - 587 KB) None None PREA Paricalcitol - Zemplar AbbVie Inc. Medical (PDF - 3 MB)

CDTL (PDF - 1 MB)

Clinical pharmacology (PDF - 2 MB) Statistical (PDF - 427 KB) PREA Patiromer - Veltassa Vifor Pharma, Inc. Medical (PDF - 3 MB) None None PREA

Pegfilgrastim-cbqv - UDENYCA   

Coherus BioSciences, Inc 

Medical (PDF - 184 KB)

Medical (PDF - 228 KB)

CDTL (PDF - 584 KB)

Clinical pharmacology (PDF - 968 KB) Statistical (PDF - 199 KB) PREA  Pegfilgrastim-fpgk - Stimufend Fresenius Kabi USA, LLC CDTL (PDF - 198 KB) None None PREA Pegfilgrastim-bmez - Ziextenzo Sandoz Inc. CDTL (PDF - 348 KB) None None PREA Peginterferon alfa-2a - Pegays Hoffmann-La Roche, Incorporated Medical (PDF - 799 KB) Clinical pharmacology (PDF - 667 KB) Statistical (PDF - 667 KB) PREA Peramivir  - Rapivab BioCryst Pharmaceuticals, Inc. Medical (PDF - 767 KB Clinical pharmacology (PDF -468 KB) Statistical (PDF - 767KB) PREA Peramivir  - Rapivab 
  BioCryst Pharmaceuticals, Inc. Medical (PDF - 1 MB Clinical pharmacology (PDF - 81 KB) None PREA Perampanel - Fycompa Eisai, Inc. Medical (PDF - 5 MB) Clinical pharmacology (PDF -6MB) Statistical (PDF -1.2MB) PREA Perampanel - Fycompa Eisai, Inc. Medical (PDF - 3 MB)
Medical (PDF - 2 MB) Clinical pharmacology (PDF -4MB) Statistical (PDF -1.3MB) PREA Perampanel - Fycompa Eisai Inc. Medical (PDF - 3 MB)

Medical MTL (PDF - 678 KB)

Clinical pharmacology (PDF -1.2MB) None PREA Perampanel - Fycompa Eisai Inc. Medical (PDF - 79 KB) Clinical pharmacology (PDF - 86 KB) None PREA

Perampanel - Fycompa

Eisai Inc. 
 

CDTL (PDF - 452 KB)

Medical (PDF - 5 MB)

 

Clinical pharmacology  (PDF - 2.5 MB) None PREA  Perflutren lipid microsphere - DEFINITY and DEFINITY RT
  Lantheus Medical Imaging, Inc. Medical (PDF - 719 KB) Clinical pharmacology (PDF - 1 MB) Statistical (PDF - 858 KB) PREA

Pentermine and topiramate - Qsymia

VIVUS LLC Medical (PDF - 9 MB) Clinical pharmacology (PDF - 587 KB) Statistical (PDF - 858 KB) PREA Phentolamine mesylate - OraVerse  Septodont Holding Sas Medical (PDF - 3 MB) None Statistical (PDF - 1 MB) PREA Phenylephrine hydrochloride ophthalmic solution Paragon BioTeck, Inc. Medical (PDF - 1MB) Clinical pharmacology (PDF - 95 KB) Statistical (PDF -1 MB) PREA

Phentolamine ophthalmic solution - Ryzumvi

Ocuphire Pharma, Inc.

CDTL (PDF - 1 MB)

Medical (PDF - 1 MB)

Clinical pharmacology (PDF - 1 MB) None PREA Phenylephrine and ketorolac - Omidria  Omeros Corporation CDTL (PDF - 1 MB)
Medical (PDF - 4 MB) None Statistical (PDF - 816 KB) BPCA Piperacillin and tazobactam - Zosyn Wyeth Pharmaceuticals LLC Medical (PDF - 2 MB) None None PREA

Pitavastatin - Livalo

Kowa Pharmaceuticals America, Inc.
CDTL Review (PDF - 526 KB)

Medical (PDF - 2 MB)

Clinical pharmacology (PDF - 3 MB)  Statistical (PDF - 240 KB) BPCA Pomalidomide - POMALYST  Celgene Corporation Medical (PDF - 15 KB) Clinical pharmacology (PDF - 1 MB) None BPCA Posaconazole - Noxafil Merck Sharp & Dohme Corp. Medical (PDF - 3 MB) Clinical pharmacology (PDF - 1 MB) Statistical (PDF - 252KB) PREA Posaconazole - Noxafil Merck Medical (PDF - 602 KB) Clinical pharmacology (PDF - 645 KB) None PREA Posaconazole - Noxafil Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc. Medical (PDF - 8 MB) None None PREA Potassium phosphate Fresenius Kabi USA, LLC Medical (PDF - 602 KB) None None PREA Potassium Phosphates - Potassium Phosphates NEW CMP Development LLC Medical (PDF - 3 MB) None None PREA Prasugrel - Effient Eli Lilly and Company Medical (PDF - 2 MB) Clinical pharmacology (PDF - 911 KB) Statistical (PDF -290 KB) BPCA Pregabalin - Lyrica Pfizer Medical (PDF - 4 MB) Clinical pharmacology (PDF - 6 KB) Statistical (PDF - 825 KB) PREA Pregabalin - Lyrica  PF PRISM CV Medical and Statistical (PDF - 1 MB) Clinical pharmacology (PDF - 1.3 MB) Medical and Statistical (PDF - 1  MB) PREA  Pregabalin - Lyrica  Pfizer

CTDL Review (PDF - 1 MB)

Medical (PDF - 1 MB)

Clinical pharmacology(PDF -1 MB) Statistical (PDF - 2 MB) BOTH Quetiapine fumarate - Seroquel and Seroquel XR AstraZeneca Pharmaceuticals LP

CTDL Review (PDF - 1 MB)

Medical (PDF - 3 MB)

Clinical pharmacology (PDF - 2 MB)

Clinical pharmacology (PDF - 739 KB)

Statistical (PDF - 785 KB) PREA Rabeprazole sodium - AcipHex Sprinkle Eisa Inc. Medical (PDF - 3 MB) Clinical pharmacology (PDF - 5 MB) Statistical (PDF 185 KB) BOTH

Ramucirumab - Cyramza

Eli Lilly and Company Medical (PDF - 198 KB) Clinical pharmacology (PDF - 168 KB) None BPCA Raltegravir - Isentress Merck Sharp Dohme Corp Medical (PDF - 1MB) Clinical pharmacology  (PDF - 2 MB) None PREA Raltegravir - Isentress Merck Sharp Dohme Corp CDTL Review (PDF - 5 MB) Clinical pharmacology  (PDF - 5 MB) Statistical (PDF 874 KB) PREA Raltegravir - Isentress   Merck Sharp Dohme Corp Medical (PDF - 1 MB) Clinical pharmacology (PDF - 1 MB) None BOTH

Ravulizumab-cwvz - Ultomiris 

Alexion Pharmaceuticals, Inc. Medical (PDF - 5 MB) None None PREA Remdesivir - Veklury Gilead Sciences, Inc.
 

Medical (PDF - 1 MB)

Medical (PDF - 776 KB)

Clinical pharmacology (PDF - 3 MB)

Statistical (PDF - 225 KB)

Statistical (PDF - 782 KB)

PREA Remdesivir - Veklury
  Gilead Sciences, Inc. CDTL (PDF - 3 MB) None None PREA Remdesivir - Veklury
  Gilead Sciences, Inc. CDTL (PDF - 3 MB) None None PREA Remdesivir - Veklury Gilead Sciences, Inc. CDTL (PDF - 4 MB) None None BOTH Reslizumab - Cinqair   Teva Respiratory, LLC Medical (PDF - 5 MB) Clinical pharmacology (PDF - 9 MB) Statistical (PDF - 2 MB) PREA Rifapentin - Priftin Sanofi US Services Inc. Medical (PDF - MB) Clinical pharmacology (PDF - 5 MB) Statistical (PDF - 3 MB) PREA Rilpivirine - Edurant  Janssen Products L.P. Medical (PDF - 2 MB) Clinical pharmacology (PDF -138 KB) None PREA Rilpivirine - Edurant Janssen Products L.P. Medical (PDF - 41 MB)

Clinical pharmacology (PDF - 2 MB)

Clinical pharmacology (PDF - 235 KB)

  PREA Rilpivirine - Edurant Janssen Products, LP Medical (PDF - 9 MB) None None BPCA Rivaroxaban - Xarelto Janssen Pharmaceuticals, Inc. Medical (PDF - 1 MB) Clinical pharmacology (PDF - 10 MB) Statistical (PDF - 797 KB) BOTH Risperidone - Risperdal Consta Janssen Pharmaceuticals, Inc. DD Summary Review (PDF - 20 KB)

CTDL Review (PDF - 1MB)

Medical (PDF - 670KB)

Medical (PDF - 667 KB)

None Statistical (PDF - 237KB) PREA Ritlecitinib - Litfulo Pfizer, Inc. Medical (PDF - 15 MB) None None PREA

Rituximab-arrx - Riabni

Amgen, Inc. Medical (PDF - 7 MB) None None PREA Rizatriptan - RizaFilm IntelGenx Corp.

Medical (PDF - 352 KB)

Memo (PDF - 851 KB)

Clinical pharmacology (PDF - 220 KB) None PREA Roflumilast - Zoryeve Arcutis Biotherapeutics, Inc. Medical (PDF - 6 MB) None None PREA

Roflumilast - Zoryeve

Arcutis Biotherapeutics, Inc. Medical (PDF - 5 MB) Clinical pharmacology (PDF - 3 MB) None PREA Roflumilast - Zoryeve Arcutis Biotherapeutics, Inc. Medical (PDF - 5 MB) None None PREA Rosuvastatin - Ezallor Sprinkle Sun Pharmaceutical Industries Limited Medical (PDF - 27 KB) None  None PREA Rufinamide - Banzel Eisai Inc. Medical (PDF - 10 MB) Clinical pharmacology (PDF - 3MB) None BPCA Ruxolitinib - Jakafi Incyte Corporation
  Medical (PDF - 685 KB) Clinical pharmacology (PDF - 533 KB) None BPCA Ruxolitinib - Jakafi Incyte Corporation Medical (PDF - 685 KB) None None BPCA

Ruxolitinib - Opzelura

Incyte Corporation Medical (PDF - 9 MB) None None PREA Ruxolitinib - Opzelura  Incyte Corporation Medical (PDF - 7 MB) None None PREA Sacubitril-valsartan - Entresto Novartis Pharmaceuticals Corp. Medical (PDF - 685 KB) Clinical pharmacology (PDF - 533 KB) Statistical (PDF -1MB) BPCA Sacubitril-valsartan - Entresto Novartis Pharmaceuticals Corp.

CDTL (PDF - 727 KB)

Medical (PDF - 9 MB)

Clinical pharmacology (PDF - 6 MB) None PREA Sapropterin dihydrochloride - Kuvan BioMarin Pharmaceutical Inc. Medical (PDF - 4 MB) Clinical pharmacology (PDF -3 MB) None BPCA Saquinavir mesylate - Invirase Hoffmann La-Roche, Inc.orporated c/o Genentech, Inc. Medical (PDF -1 MB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF -1MB) BOTH

Sarecycline - Seysara

Allergan, Inc.  Medical (PDF -1 MB)  None None PREA Secnidazole - Solosec Lupin Pharmaceuticals, Inc. Medical (PDF 4 MB)  None None PREA Secnidazole - Solosec Lupin Pharmaceuticals, Inc. (A subsidiary of Lupin Inc.) Medical (PDF 2 MB) None None PREA

Secukinuma - Cosentyx 

Novartis Pharmaceuticals Corporation Medical (PDF - 6 MB)  None None PREA Selegiline - Emsam Somerset Pharmaceuticals Medical (PDF -1 MB)

Medical 2 (PDF -1 MB)

Medical Secondary 1 (PDF - 349 KB)

Medical Secondary 2 (PDF -188 KB)

None None PREA Selenious Acid - Selenious Acid American Regent, Inc. Medical (PDF - 8 MB) None None PREA Selenious Acid - Selenious Acid American Regent, Inc. Medical (PDF - 8 MB)

None

None PREA Segesterone acetate and ethinyl estradiol vaginal systems - Annovera  The Population Council, Inc. Medical (PDF - 5 MB) None None PREA Semaglutide - Wegovy Novo Nordisk Inc.

Medical (PDF - 8 MB)

Clinical pharmacology (PDF - 16 MB) Statistical (PDF - 869 KB) PREA Serdexmethylphenidate and dexmethylphenidate - Azstarys Commave Therapeutics Multidisciplinary (PDF - 7 MB) None None PREA Sevelamer Carbonate - Renvela Genzyme/Sanofi Medical (PDF - 745 KB) Clinical pharmacology (PDF -  542 KB) Statistical (PDF - 541KB) PREA

Sitagliptin - Januvia, Janumet & Janumet XR

 

Merck Sharp & Dohme Corp.:

CDTL (PDF - 1 MB)

Medical (PDF - 4 MB)

Clinical pharmacology (PDF -  339 KB) Statistical (PDF - 623 KB) BOTH Sildenafil - Revatio Pfizer, Inc. Medical (PDF - 6 MB) Clinical pharmacology (PDF -2MB) Statistical (PDF - 508 KB) BOTH Sodium oxybate - Xyrem Jazz Pharmaceuticals
  Medical (PDF - 193 KB) Clinical pharmacology (PDF - 2MB) Statistical (PDF - 508 KB) BPCA Sodium picosulfate, magnesium oxide, and anhydrous citric acid - Prepopik Ferring Pharmaceuticals Inc. Medical (PDF - 193 KB) None None PREA  Sodium sulfate, potassium sulfate, and magnesium sulfate - Suprep Bowel Prep Kit  Sponsor: Braintree Laboratories, Inc.
  Medical (PDF - 193 KB)
  None None PREA

Sodium picosulfate, magnesium oxide and anhydrous citric acid  - Clenpiq

Ferring Pharmaceuticals Inc.

CDTL (PDF - 1 MB) None None PREA Sofpironium - Sofdra Botanix SB Inc.

Uniview (PDF - 4 MB)

Medical (PDF - 133 KB)

None None PREA Spinosad - Natroba ParaPRO, LLC Medical (PDF - 854 KB) Clinical pharmacology (PDF -171KB) None PREA Sofosbuvir - Sovaldi Gilead Sciences, Inc. Medical and CDTL (PDF - 345 KB) Clinical pharmacology (PDF - 511 KB) None PREA Sofosbuvir - Sovaldi Gilead Sciences, Inc. Medical (PDF -  218 KB) None None PREA Sofosbuvir and velpatasvir - Epclusa Gilead Sciences, Inc. Medical (PDF -  218 KB) Clinical pharmacology (PDF - 511 KB) None PREA Sofosbuvir and velpatasvir - Epclusa  Gilead Sciences, Inc. Medical (PDF -  287 KB) Clinical pharmacology (PDF - 4 MB) None BOTH Solifenacin succinate - VESIcare Astellas Pharma Global Development, Inc. Medical (PDF - 2 MB) Clinical pharmacology (PDF - 933KB) Statistical PDF - 960 KB) BOTH Solifenacin succinate - VESIcare Astellas Pharma Global Development, Inc. Medical (PDF - 3 MB)

CDTL (PDF - 1 MB)

Clinical pharmacology (PDF -2MB) Statistical (PDF - 960 KB) BOTH Spinosad - Natroba ParaPRO LLC Medical (PDF - 458 KB) None None PREA Sulfur Hexafluoride Lipid-Type A Microspheres) for Injectable Suspension - Lumason Bracco Diagnostics Inc. Medical (PDF - 5 MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -792KB) PREA Sulfur Hexafluoride Lipid-Type A Microspheres - Lumason Bracco Diagnostics, Inc. Medical (PDF - 3MB)

CDTL (PDF - 1 MB)

Clinical pharmacology (PDF - 1MB) Statistical (PDF - 859 KB) PREA Sulfur Hexafluoride Lipid-Type A Microspheres - Lumason  Bracco Diagnostics, Inc. Medical (PDF - 2 MB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF -843 KB) PREA Sugammadex - Bridion 
  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Medical (PDF - 3 MB Clinical pharmacology (PDF - 2 MB)
  Statistical (PDF - 2 MB) PREA Sumatriptan/Naproxen - Treximet Pernix Therapeutics Medical (PDF - 2 MB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF -843 KB)

Statistical Addendum (PDF -702 KB)

BOTH Sunitinib malate - Sutent  C.P. Pharmaceuticals International C.V. CDTL (PDF - 680 KB) None  None BPCA Tacrolimus - Astagraf XL

Astellas Pharma US, Inc.

 

Medical (PDF - 749 KB) None None PREA Tadalafil - Cialis Eli Lilly and Company Medical (PDF - 1 MB) Clinical pharmacology (PDF - 1 MB) None BPCA Tapentadol - Nucynta Collegium Pharmaceutical, Inc. CDTL - DD (PDF - 9 MB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF -700 KB) PREA Tavaborole - Kerydin  Anacor Pharmaceuticals, Inc. Multi-disciplinary review (PDF - 2.5 MB) None None BOTH Tazarotene - Arazlo Bausch Health US, LLC Clinical (PDF -  1 MB) None None PREA Tbo-filgrastim - Granix  Sicor Biotech UAB c/o Teva Branded Pharmaceutical Products R&D

CDTL (PDF -  176 KB)

Clinical (PDF -  196 KB)

Clinical pharmacology  (PDF - 434 KB) None BOTH Technetium 99m Tilmanocept - Lymphoseek Cardinal Health 414, LLC Multidisciplinary (PDF - 2 MB) None None PREA Kit for the Preparation of Technetium Tc 99m Succimer Injection -NephroScan Theragnostics Inc Medical (PDF - 5 MB) None None PREA Tedizolid phosphate - Sivextro  Cubist Pharmaceuticals, LLC Medical (PDF - 9 MB) None None PREA Teduglutide - GattexShire Shire-NPS Pharmaceuticals, Inc. Medical (PDF - 9 MB) None None PREA Tenofovir alafenamide - Vemlidy Gilead Sciences, Inc Medical (PDF - 2 MB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 624 KB) PREA Tenofovir disoproxil fumarate - Viread Gilead Sciences Medical (PDF - 2 MB) Clinical pharmacology (PDF - 1 MB) Statistical (PDF - 1 MB) PREA Tenofovir disoproxil fumarate - Viread Gilead Sciences CDTL (PDF - 873 KB) Clinical pharmacology (PDF - 180 KB) Statistical (PDF - 149 KB)  BOTH Teplizumab-mzwv -Tzield Provention Bio, Inc.

CDTL (PDF - 5 MB)

Medical (PDF - 284 KB)

Clinical pharmacology (PDF - 6 MB) None PREA Teriflunomide - Aubagio  Sanofi

CTDL (PDF - 3 MB)

Clinical (PDF - 3 MB)

Clinical pharmacology (PDF - 2 MB) Statistical (PDF - 410KB) BOTH Tetracaine hydrochloride - Steri-Unit Alcon Research, Ltd. DD Medical Summary (PDF - 2 MB)

Medical (PDF - 1 MB)

Clinical pharmacology (PDF - 158 KB) Statistical (PDF - 2 MB) PREA Tetracaine HCl and Oxymetazoline HCl - Kovanaze  St. Renatus, LLC Medical (PDF - 12 MB) Clinical pharmacology (PDF - 11 MB) Statistical (PDF - 2 MB) PREA

Tezepelumab -Tezspir 

AstraZeneca Medical (PDF - 10 MB) None None PREA Ticagrelor - Brilinta 
  AstraZeneca Pharmaceuticals LP Medical (PDF - 10 MB) Clinical pharmacology (PDF - 1 MB) Statistical (PDF - 325 KB) BPCA Tilmanocept - Lymphoseek
  Cardinal Health 414, LLC Medical (PDF - 2 MB) None None PREA Tiotropium bromide - Spiriva Respimat Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF -11.9MB)

Medical Addendum (PDF - 418 KB

Clinical pharmacology (PDF - 6 MB) Statistical (PDF - 1 MB)

Statistical Addendum (PDF - 327 KB)

PREA Tiotropium bromide - Spiriva Respimat  Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF -  5 MB) Clinical pharmacology (PDF - 2MB) Statistical (PDF - 432K B) BOTH Tobramycin 300 mg/4mL inhalation solution - Bethkis Cornerstone Therapeutics Medical (PDF - 5 MB) Clinical pharmacology (PDF - 78 KB) Statistical (PDF - 687 KB) PREA

Tocilizumab - Actemra 

Genentech, Inc.

Medical (PDF - 72 KB)

Medical (PDF - 109 KB)

Clinical pharmacology (PDF - 195 KB) None  PREA

Tocilizumab - Actemra 

 

Genentech, Inc. Medical (PDF - 8 MB) None None BOTH Tocilizumab-bavi - Tofidence Biogen MA Inc Medical (PDF - 5 MB) None None PREA Tocilizumab-aazg -Tyenne Fresenius Kabi USA, LLC

CDTL (PDF - 42K B)

Medical (PDF - 8 MB)

None None

PREA

Tofacitinib - Xeljanz Pfizer, Inc. Medical (PDF - 8 MB) None None PREA Topiramate - Topamax Janssen Pharmaceuticals, Inc. Medical (PDF - 8 MB) None Statistical (PDF - 881 KB) PREA

Topiramate - Eprontia 

Azurity Pharmaceuticals, Inc. Medical (PDF - 669 KB) Clinical pharmacology  (PDF -  565 KB) None PREA Trabectedin - Yondelis Janssen Products, LP Medical (PDF - 3 MB) Clinical pharmacology  (PDF - 683 KB) None BPCA Trace elements injection 4 - Tralement American Regent, Inc. Medical (PDF - 2.5 MB) None None PREA Trace elements injection 4 - Tralement American Regent, Inc. Medical (PDF - 321 KB) None None PREA Tralokinumab-ldrm - Adbry LEO Pharma A/S c/o LEO Pharma Inc

Unireview (PDF - 4MB)

Medical (PDF - 32 KB)

None None PREA Trametinib - Mekinist Novartis Pharmaceuticals Corporation
  Medical (PDF - 18 MB) None None PREA Trametinib - Mekinist Novartis Pharmaceuticals Corporation Medical (PDF - 800 KB) Clinical pharmacology  (PDF - 616 KB) None BPCA Tranexamic acid - Lysteda Ferring Pharmaceuticals, Inc. None Clinical pharmacology (PDF - 1 MB) None PREA Tretinoin lotion - Altreno    Dow Pharmaceutical Sciences, Inc. Medical (PDF -  3 MB) None None PREA Tretinoin and benzoyl peroxide - Twyneo   Sol-Gel Technologies Ltd. c/o B&H Consulting Services Inc. Medical (PDF - 2 MB) None None PREA Trifarotene - Aklief Galderma Research and Development Medical (PDF - 3 MB) None None PREA Trofinetide - Daybue  Acadia Pharmaceuticals Inc

Medical (PDF - 212 KB)

Medical (PDF - 6 MB)

Clinical pharmacology (PDF - 6 MB)

Statistical (PDF - 2 MB)

Statistical Errata (PDF - 28 KB)

BPCA Tropicamide and phenylephrine - MYDCOMBI Eyenovia, Inc. CDTL - DD (PDF - 6 MB) None Statistical (PDF - 2 MB) PREA Upadacitinib - Rinvoq  AbbVie Inc. Medical (PDF - 10 MB) None None PREA Upadacitinib - Rinvoq and Rinvoq LQ AbbVie Inc. Medical (PDF - 4 MB) None None PREA Ustekinumab - Stelara Janssen Biotech, Inc. Medical (PDF - 352 MB) Clinical pharmacology (PDF - 3 MB) None PREA Ustekinumab - Stelara Janssen Biotech, Inc. Medical (PDF - 8 MB) None None PREA Ustekinumab-aekn - Selarsdi Alvotech USA Inc. PharmaLex US Corporation

CDTL (PDF - 123 KB)

Medical (PDF - 5 MB)

Clinical pharmacology (PDF - 9 KB) None PREA Valganciclovir hydrochloride - Valcyte Roche Palo Alto LLC c/o Genentech, Inc.orporated Medical (PDF - 3 MB) Clinical pharmacology (PDF - 6 MB) None PREA

Valsartan - Diovan

Novartis Pharmaceuticals Corporation Medical (PDF - 2 MB) None None PREA

Varenicline - Chantix

 

 

PF Prism C V  None Clinical pharmacology (PDF - 3 MB) None BOTH Vilazodone hydrochloride - Viibryd  Allergan Sales, LLC Medical (PDF - 3 MB) None None BOTH

Vortioxetine - Trintellix 

Takeda Pharmaceuticals, USA, Inc. Medical (PDF - 3 MB) None None BOTH Vortioxetine - Trintellix Takeda Pharmaceuticals, USA, Inc. Medical (PDF - 3 MB) None None BOTH Ustekinumab - Stelara Janssen Biotech Inc.

CDTL (PDF - 593 KB)

Medical (PDF - 5 MB)

Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 275 KB) PREA  Vigabatrin - Sabril Lundbeck LLC. Medical (PDF - 4MB) Clinical pharmacology (PDF - 2.3MB) Statistical (PDF - 698KB) BOTH Viloxazine extended release capsules - Qelbree
  Supernus Pharmaceuticals, Inc.

Medical (PDF - 13 KB)

Medical (PDF - 13 MB)

None None PREA Viloxazine extended-release capsules - Qelbree Supernus Pharmaceuticals, Inc. Medical (PDF - 2 MB) None None PREA Voriconazole - Vend PF PRISM C.V.

Medical (PDF - 2 MB)

Medical PDF - 200 KB)

Clinical Pharmacology (PDF - 1 MB) Statistical (PDF -  200 KB) PREA Xenon Xe 129 hyperpolarized - XENOVIEW Polarean Inc. Medical PDF - 200 KB) None None PREA Zinc sulfate - None  American Regent, Inc. Medical (PDF -  4 MB) None None PREA Ziprasidone - Geodon
  Viatris Specialty LLC Medical (PDF -  2 MB) None None PREA Zolmitriptan - Zomig  AstraZeneca Pharmaceuticals LP Medical (PDF - 5 MB) None Statistical (PDF - 3 MB) PREA