(AGENPARL) - Roma, 29 Giugno 2022

(AGENPARL) – SILVER SPRING mer 29 giugno 2022

Drug  Sponsor Medical Review Clinical Pharmacology Review Statistical Review BPCA or PREA or Both

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x x Medical (PDF -x) Clinical pharmacology (PDF -x) Statistical (PDF -x) x

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Abacavir and Lamivudine – Epzicom ViiV Healthcare Company Medical (PDF – 2.8 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 sulfate – Ziagen ViiV Healthcare Company Medical (PDF – 4.2 M B) Clinical pharmacology (PDF – 3 MB) Statistical (PDF – 4.7 MB) PREA Abatacept – Orencia Bristol-Myers Squibb Company

Medical (PDF – 259 KB)

Medical Addendum (PDF – 469 KB)

Clinical pharmacology (PDF – 2.3 MB)

Clinical pharmacology (PDF – 269 KB)

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 Acetaminophen – Ofirmev MallInc.krodt, Inc. Medical (PDF – 1.3 MB) Clinical pharmacology (PDF – 5.4 MB) Statistical (PDF -378 KB) PREA Abrocitinib – Cibinqo
  Pfizer Inc. Medical (PDF – 10 MB) None None PREA Acyclovir 5%, hydrocortisone 1% – Xerese   Valeant International Bermuda Medical (PDF -885 KB) None None PREA Acyclovir sodium – Zovirax  GlaxoSmithKline, LLC None Clinical pharmacology (PDF – 3 MB) None  PREA Adalimumab-adaz – Hyrimoz
  Sandoz Inc.

Medical (PDF – 2 MB)

CDTL Review (PDF – 300 MB)

None None PREA Adalimumab-aqvh – Yusimry   Coherus BioSciences, Inc Medical (PDF – 5 MB) None None PREA Adalimumab-atto – Amjevita Amgen Inc.

CDTL Review (PDF – 4.3 MB)

Medical (PDF – 199K B)

Medical (PDF – 336KB)

DD Summary Review (PDF – 2.9 MB)
 

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

Statistical  (PDF – 363 KB)

Statistical (PDF – 717 KB)

 PREA Adalimumab-fkjp – Hulio Mylan Pharmaceuticals Inc. Medical (PDF – 2.2 MB) None None PREA Adalimumab – Humira AbbVie,Inc. Medical (PDF – 2.2 MB) None None PREA Adapalene and benzoyl peroxide – Epiduo Galderma Laboratories, LP Medical (PDF – 2.2 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 -3.6 MB) Statistical (PDF -1.6 MB) PREA

Afatini – Gilotrif

Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF – 5 MB) None None BPCA Anidulafungin – Eraxis Vicuron Holdings LLC, a subsidiary of Pfizer Inc. Medical (PDF – 5 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 -2.2 MB) PREA Albuterol sulfate – ProAir RespiClick  Teva Branded Pharmaceutical Products R&D, Inc. Medical (PDF – 859 KB) Clinical pharmacology (PDF -2.5 MB) Statistical (PDF -1.1 MB) PREA Aliskiren – Tekturna Noden Pharma DAC CDTL (PDF –  310 KB) Clinical pharmacology (PDF -3.3 MB) Statistical (PDF – 442 KB) BPCA

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 – 4.1 KB) None PREA Amphetamine Extended-Release Orally Disintegrating Tablets – Adzenys XR-ODT  Neos Therapeutics, Inc. Medical (PDF – 470 KB) Clinical pharmacology (PDF -3.3 MB) None PREA Amphetamine – Dyanavel XR Tris Pharma Medical (PDF – 1.8 MB) Clinical pharmacology (PDF -4.8 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 Aprepitant – Emend Merck Sharp & Dohme Corp. Medical (PDF – 5.7 MB)

Medical Addendum (PDF -1.1 MB)

Medical DD memo (PDF -2.9 MB)

Clinical pharmacology (PDF -5  MB)

Clinical pharmacology addendum (PDF -424 KB)

Statistical (PDF -1.4 MB) PREA Aprepitant – Emend Merck Sharp & Dohme Corp. Medical (PDF – 553 KB) Clinical pharmacology (PDF – 5 MB)

Addendum (PDF -105KB)

Statistical (PDF -1.2MB) PREA Aprepitant – Emend Merck Sharp & Dohme Corp.

Medical (PDF – 5 MB)

Medical Addendum (PDF -1.1 MB)

Medical DD memo (PDF – 2.9 MB)

Clinical pharmacology (PDF – 5MB)

Addendum (PDF – 105KB)

Statistical (PDF -1.2MB) PREA Aripiprazole – Abilify Otsuka Medical (PDF – 2.4MB) None Statistical (PDF -409KB) PREA Asenapine – Saphris Forest Laboratories, Inc. Medical (PDF – 5.4MB)

Medical (PDF – 4MB)

Clinical pharmacology (PDF -3.8MB) Statistical (PDF -3MB) BPCA Asparaginase erwinia chrysanthemi (recombinant)- rywn – RYLAZE  Jazz Pharmaceuticals Ireland Limited Medical (PDF – 4 MB) None None PREAW Atazanavir and cobicistat – Evotaz Bristol-Myers Squibb Company CDTL (PDF – 402 KB) Clinical pharmacology (PDF -1MB) None PREA Atazanavir – Reyataz Bristol-Myers Squibb Company Medical (PDF – 14.1MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -1.9MB) BOTH Atazanavir – Reyataz  Bristol-Myers Squibb Company Medical (PDF – 1.6MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -3.9MB) BOTH Atazanavir – Reyataz  Bristol-Myers Squibb Company Medical (PDF – 461 KB) Clinical pharmacology (PDF – 318 KB) S Statistical (PDF – 682 KB)

BOTH 

Atezolizumab – TECENTRIQ

Genentech, Inc. Medical (PDF – 1 MB) None 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 PREA Azelastine hydrochloride and Fluticasone propionate – Dymista Meda Pharmaceuticals, Inc. Medical (PDF – 2.9MB) None Statistical (PDF -2.1MB) BPCA 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 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 -702KB) Statistical (PDF -1.2MB) 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 -1.5MB) Statistical (PDF -959KB) PREA

Belumosudil – Rezurock

Kadmon Pharmaceuticals, LLC Medical (PDF – 7MB) Non None PRE Belimumab – Benlysta  Human Genome Sciences Medical (PDF – 6 MB) None None PREA Benralizumab – Fasenra AstraZeneca AB Medical (PDF – 1.7 MB) Clinical pharmacology (PDF -7 MB) Statistical (PDF – 2 MB) PREA 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 – 3.4MB)

Medical (PDF – 1.6MB)

None Statistical (PDF -946KB)

Statistical Addendum (PDF – 127KB)

PREA

Blinatumomab – Blincyto

 Amgen, Inc. Medical (PDF – 9 MB) Clinical pharmacology (PDF -1.2MB) Statistical (PDF -374KB) BPCA Bortezomib – Velcade Millennium Pharmaceuticals, Inc. Medical (PDF – 3.5MB) Clinical pharmacology (PDF -1.2MB) Statistical (PDF -374KB) BPCA Budesonide – Entocort EC Elan Pharma International Medical (PDF – 2.9MB) Clinical pharmacology (PDF -2.8MB) Clinical pharmacology (PDF -2.8MB) PREA Brexpiprazole – Rexulti
  Otsuka Pharmaceutical Company, Ltd. Medical (PDF – 4 MB) None None PREA Brimonidine tartrate – Lumify Bausch + Lomb CDTL Review (PDF – 2.5 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) PREA 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 BPCA 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 -564KB) 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 PREA 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 Capecitabine – Xeloda Hoffmann-La Roche, Inc. Medical (PDF – 4MB) Clinical pharmacology (PDF – 1MB) Statistical (PDF -610KB) BPCA Carbinoxamine maleate – Karbinal ER Tris Pharma, Inc. Medical (PDF – 1.4MB) Clinical pharmacology (PDF – 500KB) 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 – 10.9MB)

Medical CTDL (PDF -1.5MB)

Clinical pharmacology (PDF – 3MB) Statistical (PDF -1.2MB) BPCA 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 Cetirizine ophthalmic solution – Zerviate Nicox Ophthalmics, Inc.

Medical Resubmission (PDF – 231 KB)

Medical (PDF – 4.9 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 – 5MB)

Clinical pharmacology (PDF -1.3MB) Statistical (PDF -674KB) PREA Cinacalcet hydrochloride – Sensipar  

CDTL (PDF – 2.2 MB)

Medical (PDF – 4.1 MB)

Clinical pharmacology (PDF – 5.6 MB) Statistical (PDF – 957 KB) PREA Ciprofloxacin 0.3% and Fluocinolone acetonide 0.025% – Otovel Otic Solution Laboratorios SALVAT, S.A. Medical (PDF – 4MB) Clinical pharmacology (PDF -632KB) 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 -97KB) Statistical (PDF -896KB)

Addendum (PDF -157KB

PREA Ciprofloxacin ophthalmic solution – Ciloxa Novartis Pharmaceuticals Corporation

Medical (PDF – 110 KB)

Medical (PDF – 173 KB)

None None BPCA 

Clascoterone – Winlevi

Cassiopea SpA Medical (PDF – 2.6MB) None None PREA Clindamycin phosphate –  Xaciato  Daré Bioscience Inc. Medical (PDF – 2.6MB) None None PREA Clonidine – Kapvay Concordia Pharms Inc. Medical (PDF – 2.6MB) None Statistical (PDF -2MB) PREA Cobicistat – Tybost Gilead Sciences, Inc. CDTL (PDF – 1 MB) Clinical pharmacology (PDF – 1 MB) None PREA Colesevelam HCl – Welchol Daiichi Sankyo Inc. CDTL (PDF – 2MB)

Medical (PDF – 12MB)

Clinical pharmacology (PDF – 7MB) 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 Cysteamine bitartrate – Procysbi Raptor Pharmaceuticals, Inc. Medical (PDF -12MB) Clinical pharmacology (PDF -1.3MB)

Clinical pharmacology addendum (PDF -420KB)

None BPCA Cysteamine bitartrate – Procysbi Horizon Pharma USA, Inc.
  Medical (PDF – 2 MB) Clinical pharmacology (PDF – 1.2MB) Statistical (PDF – 1MB) BPCA Dabigatran etexilate – Pradaxa 
  Boehringer Ingelheim Pharmaceuticals, Inc.

Medical (PDF – 2 MB)

Medical (PDF – 700 KB)

Clinical pharmacology (PDF –  5 MB) None BPCA

Dalbavancin hydrochloride – Dalvance

Allergan Sales, LLC Medical (PDF – 2 MB) None None BPCA 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 Dapsone – Aczone 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  Darbepoetin alfa – Aranesp Amgen Inc. Medical (PDF -1.6MB) 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 PREA Decitabine – Dacogen  Eisai Inc. Medical (PDF -2MB) Clinical pharmacology (PDF -1MB) None BPCA Deferasirox – Jadenu Novartis Pharmaceuticals Corporation Medical (PDF – 9 MB) Clinical pharmacology (PDF – 1.5MB) Statistical (PDF – 2MB) PREA 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 PREA 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 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 -748KB) Clinical pharmacology (PDF -40KB) Statistical (PDF -479KB) BPCA Dolutegravir – Tivicay ViiV Healthcare Medical (PDF -7.8MB) Clinical pharmacology (PDF -10.8MB) Statistical (PDF -4MB) PREA Dolutegravir – Tivicay  ViiV Healthcare Medical (PDF -1.6MB)

CDTL Review (PDF -932KB)

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 -241KB) Clinical pharmacology (PDF -89KB) Statistical (PDF -131KB) PREA Drospirenone and estetrol tablets – Nextstellis  
  Mayne Pharma LLC Medical (PDF – 3 MB) None None PREA Drospirenon – Slynd Exeltis USA, Inc Medical (PDF – 1 MB) None None PREA Duloxetine – Cymbalta Eli Lilly and Company, Inc. Medical (PDF -2.2 MB) Clinical pharmacology (PDF -197KB) Statistical (PDF -2.8MB) PREA Duloxetine – Cymbalta  Eli Lily and Company, Inc. Medical (PDF -2.2 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 – 8MB) Clinical pharmacology (PDF -959KB) Statistical (PDF -665KB) BPCA Dupilumab – Dupixent Regeneron Pharmaceuticals, Inc. Medical (PDF – 8MB) None None PREA Dupilumab – Dupixent Regeneron Pharmaceuticals, Inc. Medical (PDF – 8MB) None None PREA Econazole nitrate – Ecoza AmDerma Pharmaceuticals, LLC Medical (PDF -2 MB) Clinical pharmacology (PDF -2.5MB) Statistical (PDF -422KB) 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 BPCA 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)     Eltrombopag – Promacta  Novartis Pharmaceuticals Corporation Medical (PDF -3.5MB) Clinical pharmacology (PDF -1.2MB) Statistical (PDF -1MB) BPCA Eltrombopag – Promacta  Novartis Pharmaceuticals Corporation Medical (PDF – 58 KB) None None  PREA 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 PREA Elvitegravir, Cobicistat, Emtricitabine/Tenofovir Disoproxil Fumarate – Stribild Gilead Sciences, Inc. CTDL Review (PDF -359KB) Clinical pharmacology (PDF – 462KB) None PREA Emtricitabine, Rilpivirine, and Tenofovir alafenamide – Odefsey Gilead Sciences, Inc. Medical (PDF -310KB)

CTDL Review (PDF -578KB)

Clinical pharmacology (PDF -5MB)

Clinical pharmacology addendum (PDF -297KB)

None PREA Emtricitabine, Rilpivirine, and Tenofovir alafenamide – Descovy Gilead Sciences, Inc. Medical (PDF -1.27MB)

Addendum (PDF -572KB)

Clinical pharmacology (PDF -7.6MB) Statistical (PDF -1.9MB) PREA Emtricitabine, Rilpivirine, and Tenofovir alafenamide – Descovy Gilead Sciences, Inc. Medical (PDF -1.27MB) Clinical pharmacology (PDF -7.6MB) Statistical (PDF -1.9MB) PREA Emtricitabine and tenofovir alafenamide – Descovy Gilead Sciences, Inc. Medical (PDF – 642 KB) Clinical pharmacology (PDF -145KB) 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 -145KB) 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 -3.4MB) Clinical pharmacology (PDF -3MB) Statistical (PDF -660KB) BPCA Entrectinib – Rozlytrek  Genentech Medical (PDF – 23 MB) None None BPCA Erlotinib – Tarceva OSI Pharmaceuticals, LLC Medical (PDF -6.2MB) Clinical pharmacology (PDF -2.2MB) None BPCA Epinephrine – Auvi-Q Kaleo, Inc. Medical (PDF – 1.8 MB) None None PREA Escitalopram oxalate – Lexapro Forest Laboratories, Inc. Medical (PDF -218KB) None None BPCA 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 BPCA 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-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 Etravirine – Intelence Janssen Products, LP Medical (PDF -1.4MB) Clinical pharmacology (PDF -1.7MB) None PREA Etravirine – Intelence Janssen Products, LP Medical (PDF -1 MB) Clinical pharmacology (PDF – 896 KB) None BPCA 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) BPCA Fenfluramine HCl – Fintepla
  Zogenix, Inc. Medical (PDF – 588 KB) Clinical pharmacology (PDF – 2 MB) None PREA 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) BPCA Fingolimod – Gilenya  Novartis Pharmaceuticals Corporation

CDTL Review (PDF – 2 MB)

Medical (PDF – 3.8 MB)

Clinical pharmacology (PDF -2MB) Statistical (PDF -3.2MB) 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/Umeclidinium/Vilanterol – Trelegy Ellipta   GlaxoSmithKline Intellectual Property Development Ltd. England Medical (PDF -3MB) None None PREA Fluticasone propionate Lotion – Cutivate Fougera Pharmaceuticals Inc. Medical (PDF -3MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -317MB) PREA 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 PREA 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)       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) BPCA 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 PREA 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 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 PREA Gatifloxacin – Zymar   Allergan, Inc. DDTL (PDF – 428 KB) 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 BPCA 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 BPCA Ibrexafungerp – Brexafemme  SCYNEXIS, Inc. Medical (PDF – 10 MB) None 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

Indocyanine green for Injection – Spy Agent Green

Novadaq Technologies ULC Medical (PDF – 4 MB)   None None 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 Iodixanol – Visipaque

GE HealthCare Inc.

CDTL Review (PDF –  2.4 MB)

Medical (PDF – 1.9  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  5.5 MB) Clinical pharmacology (PDF – 1.6 MB) None PREA Iron Sucrose Injection, USP – Venofer Luitpold Pharmaceuticals, Inc. Medical (PDF -2 MB) Clinical pharmacology (PDF – 114 KB) Statistical (PDF – 576 KB) PREA Ivabradine – Corlanor  Amgen Inc.

CDTL (PDF – 3 MB)

Medical (PDF – 4 MB)

Clinical pharmacology (PDF – 4 MB) Statistical (PDF – 51 KB) BPCA Ixekizumab – Taltz Eli Lilly and Company Medical (PDF – 2 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 – 376 KB) 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 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 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 PREA Ledipasvir-sofosbuvir – Harvoni Gilead Sciences, Inc. Medical (PDF – 280 KB) None None BPCA Leuprolide acetate – Fensolvi Tolmar, Inc. Medical (PDF – 280 KB) Clinical pharmacology (PDF – 3.9 MB Statistical (PDF – 2 MB) PREA Levalbuterol hydrochloride – Xopenex Oak Pharmaceuticals Medical (PDF -8.3 MB) Clinical pharmacology (PDF – 3.9 MB) Statistical (PDF – 2 MB) PREA Levalbuterol tartrate – Xopenex HFA Sunovion Pharmaceuticals Inc. Medical (PDF -3.9 MB) Clinical pharmacology (PDF – 1.2 MB) Statistical (PDF 1.3 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 – 202KB)

CDTL Review (PDF – 371 KB)

Medical (PDF – 327KB)

Clinical pharmacology (PDF – 1.2 MB) None PREA Levonorgestrel – Liletta Medicines360 Medical (PDF – 8.8 MB) Clinical pharmacology (PDF – 1M B)

Clinical pharmacology (PDF – 2.4 MB)

Statistical (PDF – 1.5 MB) PREA Levonorgestrel/ethinyl estradiol tablets  Exeltis

CDTL (PDF – 8.8 MB)

Medical (PDF – 8.8 MB)

Medical (PDF – 8.8 MB)

Clinical pharmacology (PDF – 1M B)

Clinical pharmacology (PDF – 2.4 MB)

Statistical (PDF – 1.5 MB) PREA Levonorgestrel/ethinyl estradiol and ethinyl estradiol – Quartette Teva Branded Pharmaceutical Products R&D, Inc. Medical (PDF -6MB) 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 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) BPCA Lisdexamfetamine dimesylate – Vyvanse  Shire Development, LLC Medical (PDF –  218 KB) Clinical pharmacology (PDF – 1 MB) None PREA 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 BPCA Liisenatide – Adlyxin 
  Sanofi-aventis U.S. LLC Medical (PDF –  182 MB) Clinical pharmacology (PDF – 1 MB) 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) PREA 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 – 1.9 MB) PREA Lubiprostone – Amitizia Sucampo Pharmaceuticals Inc. Medical (PDF – 11 MB) Clinical pharmacology (PDF – 1 MB) Statistical (PDF – 1 MB) PREA 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)

 PREA 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 – 1.0 MB) None None PREA Maraviroc – Selzentry Viiv Healthcare Medical (PDF – 1.0 MB) Clinical pharmacology (PDF – 2.8 MB) None PREA Maraviroc – Selzentry Viiv Healthcare Medical (PDF – 1 MB) Clinical pharmacology (PDF – 3 MB) None PREA Memantine hydrochloride – Namenda XR Forest Research Institute, Inc. (subsidiary of Forest Laboratories Inc.) Medical (PDF – 2.1 MB) Clinical pharmacology (PDF – 956 KB) Statistical (PDF – 1.1 MB) BPCA Mepolizumab – Nucala GlaxoSmithKline LLC Medical (PDF – 8 MB) Clinical pharmacology (PDF – 6 MB)

Clinical pharmacology addendum (PDF -425KB)

Statistical (PDF – 1.4 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 – 13MB)

Clinical pharmacology (PDF – 2.8MB)

Statistical (PDF – 168KB) BPCA Mesalamine – Asacol HD Warner Chilcott Medical (PDF – 6MB) Clinical pharmacology (PDF – 3.2 MB)

Clinical pharmacology (PDF – 518 KB)

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

Medical Addendum(PDF – 495 KB)

Clinical pharmacology (PDF -116KB) None PREA Mesalamine – Delzicol  Warner Chilcott (US), LLC Medical (PDF – 4.7 MB) Clinical pharmacology (PDF – 729 KB) Statistical (PDF – 1.1KB) PREA Mesalamine – Lialda  Shire Development, LLC Medical (PDF – 6 MB)      

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 – 2.6 MB) Statistical (PDF – 1.4 MB) PREA

Methylphenidate hydrochloride extended-release – Aptensio XR

Rhodes Pharmaceuticals L.P. Medical (PDF – 2.3 MB) Clinical pharmacology (PDF – 3.6M B) Statistical (PDF – 1.1 MB)
Statistical (PDF – 629 KB) PREA 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 -1.3MB)

Medical (PDF – 4.8 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 – 4.8 MB)

Clinical pharmacology (PDF – 2 MB) 

Statistical (PDF – 1 MB)

Statistical (PDF –  2 MB) 

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) 

BPCA

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 Metoprolol Succinate – KAPSPARGO SPRINKLE Sun Sun Pharmaceutical Industries LimitedPharmaceutical Industries Limited Medical (PDF – 799 KB) Clinical pharmacology (PDF – 978 KB) None PREA Metronidazole vaginal gel 1.3% – Nuvessa Chemo Research SL Medical (PDF – 1.2 MB) Clinical pharmacology (PDF – 70 KB) Statistical (PDF – 127 KB) PREA  Micafungin for injection – Mycamine Astellas Pharma US, Inc. Medical (PDF – 1.2 MB) None None BPCA Micafungin sodium – Mycamine Astellas Pharma US, Inc. Medical (PDF – 2.2 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 BPCA Mixed salts of a single-entity amphetamine product – Mydayis  Shire Development, LLC.

Medical (PDF – 6.8 MB)

Clinical pharmacology  (PDF -1.8KB) Statistical (PDF -987KB) PREA Mixed salts of a single entity amphetamine product – Mydayis  Shire Development, LLC. Medical (PDF – 6.8 MB) None None BPCA Mometasone furoate – Asmanex HFA Merck Sharp & Dohme Corp. Medical (PDF -2.7MB) Clinical pharmacology (PDF -1.5MB) Statistical (PDF -603KB) PREA Mometasone furoate – Asmanex HFA Merck Sharp & Dohm Corp Medical (PDF-1MB) None None PREA Mometasone furoate and formoterol fumarate – Dulera Schering-Plough Medical (PDF-1MB) None None PREA Morphine sulfate injection Hospira, Inc. CDTL (PDF – 2 MB) None None PREA

Moxifloxacin – Avelox

Bayer Pharmaceuticals Medical (PDF- 905KB) Clinical pharmacology (PDF -1.8MB) Statistical (PDF – 760KB) PREA Moxifloxacin ophthalmic solution – Vigamox Alcon Pharmaceuticals, Ltd. Medical (PDF – 434 KB)

DD Summary Review (PDF- 118 KB)

None None BPCA 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 – 1.2MB) Clinical pharmacology (PDF -1.6MB) Statistical (PDF – 822KB)  PREA Naloxone hydrochloride – Narcan Nasal Spray  Adapt Pharma Operations Limited DD Summary Review(PDF -1.2MB)

CTDL Review (PDF -3MB)

Clinical pharmacology (PDF -1.5MB) None PREA Naloxone Hydrochloride Injection – Naloxone Hydrochloride Injection Kaleo, Inc. CDTL Review (PDF – 2 MB) Clinical pharmacology (PDF – 4 MB) 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 -1MB) Clinical pharmacology (PDF -1.7MB) Statistical (PDF -1.3MB) PREA Naproxen and esomeprazole magnesium – Vimovo  Horizon Pharma Inc. Medical (PDF – 3.8 MB) Clinical pharmacology (PDF -2.3 MB) None PREA Neostigmine methylsulfate – Bloxiverz Eclat Pharmaceuticals, LLC Medical (PDF -7.7MB) Clinical pharmacology (PDF -2MB) None PREA Nevirapine – Viramune XR Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF -2MB) Clinical pharmacology (PDF -446KB) Statistical (PDF – 723KB) PREA Nilotinib –  Tasigna   Sponsor: Novartis Pharmaceuticals Corporation Medical (PDF – 1.2 MB) Clinical pharmacology (PDF – 1.6 MB) Statistical (PDF – 124 KB) BPCA Nitisinone – NITYR Cycle Pharmaceuticals Ltd. Medical (PDF – 358 KB) Clinical pharmacology (PDF – 3.6 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 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 – 469KB) PREA Obiltoxaximab – Anthim Elusys Theraputics, Inc. Medical (PDF -18MB)

Addendum (PDF -249KB)

Clinical pharmacology (PDF -12MB)

Addendum (PDF -126KB)

Statistical (PDF – 9MB) PREA Ocriplasmin- Jetrea ThromboGenics, Inc. Medical (PDF – 817KB) Clinical pharmacology (PDF – 117KB) Statistical (PDF – 760KB)  PREA Olanzapine and fluoxetine hydrochloride – Symbyax Eli Lilly and Company Medical (PDF -1.3MB) Clinical pharmacology (PDF -1.2MB)

Addendum (PDF – 132KB)

Statistical (PDF – 953KB) PREA Olopatadine – Pazeo Alcon Research LTD Medical (PDF -2.3MB) Clinical pharmacology (PDF -340KB) Statistical (PDF – 4.3KB) BPCA Omalizumab – Xolair Genentech Medical (PDF -6MB) Clinical pharmacology (PDF -1.3MB) Statistical (PDF – 2MB) PREA Omalizumab – Xolair Genentech, Inc. and Novartis Pharmaceuticals Corp. Medical (PDF-4MB) Clinical pharmacology (PDF -1MB) Statistical (PDF-1 MB)  PREA

Omalizumab – Xolair

Genentech, Inc. and Novartis Pharmaceuticals Corp. Medical (PDF – 5MB) None None  PREA Omeprazole magnesium – Prilosec  AstraZeneca Pharmaceuticals LP Medical (PDF -908KB) Clinical pharmacology (PDF -1.6MB) 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 Oxcarbazepine – Oxtellar XR Supernus Pharmaceuticals, Inc. Medical (PDF – 5 MB) Clinical pharmacology (PDF – 7 MB) Statistical (PDF – 482 KB) PREA Oxycodone hydrochloride – Oxycontin Purdue Pharma L.P. Medical (PDF – 17 MB) Clinical pharmacology (PDF – 2 MB) Statistical (PDF – 678 KB) BPCA Oxycodone hydrochloride – OxyContin Purdue Pharma L.P. Medical (PDF – 17 MB) Clinical pharmacology (PDF – 16 MB) Statistical (PDF – 551 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 -15MB)

Medical (PDF -2MB)

Clinical pharmacology (PDF -2.3MB) Statistical (PDF – 771KB) BPCA Pancrelipase – Creon AbbVie Inc. Medical (PDF -566KB) None None PREA Pancrelipase – Pancreaze  Janssen Pharmaceuticals, Inc. Medical (PDF -142KB) None None PREA Pancrelipase – Pertzye Digestive Care, Inc. Medical (PDF – 1MB) None None PREA Pancrelipase – Zenpep Aptalis Pharma Limited. Medical (PDF -587KB) None None PREA Paricalcitol – Zemplar AbbVie Inc. Medical (PDF – 3.0MB)

CDTL (PDF – 1.1MB)

Clinical pharmacology (PDF – 1.9MB) Statistical (PDF – 427KB) 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  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 – 767KB 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 -4.8MB) Clinical pharmacology (PDF -6MB) Statistical (PDF -1.2MB) PREA Perampanel – Fycompa Eisai, Inc. Medical (PDF -2.9MB)
Medical (PDF -1.6MB) Clinical pharmacology (PDF -4MB) Statistical (PDF -1.3MB) PREA Perampanel – Fycompa Eisai Inc. Medical (PDF -2.6MB)

Medical  MTL (PDF -678KB)

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  Phentolamine mesylate – OraVerse  Septodont Holding Sas Medical (PDF -2.7MB) None Statistical (PDF -1.4MB) PREA Phenylephrine hydrochloride ophthalmic solution Paragon BioTeck, Inc. Medical (PDF – 1MB) Clinical pharmacology (PDF – 95KB) Statistical (PDF -1MB) 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 – 3MB) Clinical pharmacology (PDF – 1.2MB) Statistical (PDF – 252KB) PREA Posaconazole – Noxafil Merck Medical (PDF – 602KB) Clinical pharmacology (PDF –  645KB) None PREA Potassium phosphate Fresenius Kabi USA, LLC Medical (PDF – 602KB) None None PREA Prasugrel – Effient Eli Lilly and Company Medical (PDF – 2MB) Clinical pharmacology (PDF – 911KB) Statistical (PDF -290KB) BPCA Pregabalin – Lyrica Pfizer Medical (PDF –  3.8MB) Clinical pharmacology (PDF – 5.9KB) Statistical (PDF – 825KB) PREA Pregabalin – Lyrica  PF PRISM CV Medical and Statistical (PDF –  1.2 MB) Clinical pharmacology (PDF – 1.3 MB) Medical and Statistical (PDF –  1.2 MB) PREA  Pregabalin – Lyrica  Pfizer

CTDL Review (PDF – 1 MB)

Medical (PDF – 1 MB)

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

CTDL Review (PDF -1MB)

Medical (PDF – 3MB)

Clinical pharmacology(PDF -1.8MB)

Clinical pharmacology (PDF -739KB)

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

Ramucirumab – Cyramz

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 – 4.5 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 PREA

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 Reslizumab – Cinqair   Teva Respiratory, LLC Medical (PDF -5MB) Clinical pharmacology (PDF – 9 MB) Statistical (PDF -1.6MB) PREA Rifapentin – Priftin Sanofi US Services Inc. Medical (PDF -10.1MB) Clinical pharmacology (PDF -5.1MB) Statistical (PDF -3.1MB) PREA Rilpivirine – Edurant  Janssen Products L.P. Medical (PDF -2.3MB) Clinical pharmacology (PDF -138KB) None PREA Rivaroxaban – Xarelto Janssen Pharmaceuticals, Inc. Medical (PDF -1 MB) Clinical pharmacology (PDF – 10 MB) Statistical (PDF – 797 KB) BPCA Risperidone – Risperdal Consta Janssen Pharmaceuticals, Inc. DD Summary Review (PDF -20KB)

CTDL Review (PDF -1MB)

Medical (PDF -670KB)

Medical (PDF -667KB)

None Statistical (PDF -237KB) PREA

Rituximab-arrx – Riabni

Amgen, Inc. Medical (PDF – 7 MB) None None PREA Rufinamide – Banzel Eisai Inc. Medical (PDF -9.4MB) Clinical pharmacology (PDF -3MB) None BPCA Ruxolitinib – Jakafi Incyte Corporation
  Medical (PDF – 685 KB) Clinical pharmacology (PDF – 533 KB) None BPCA

Ruxolitinib – OPZELURA

Incyte Corporation Medical (PDF – 9 MB) None None PREA Sacubitril-valsartan – Entresto Novartis Pharmaceuticals Corp. Medical (PDF – 685 KB) Clinical pharmacology (PDF – 533 KB) Statistical (PDF -1MB) BPCA Sapropterin dihydrochloride – Kuvan BioMarin Pharmaceutical Inc. Medical (PDF -3.6MB) Clinical pharmacology (PDF -2.5MB) None BPCA Saquinavir mesylate – Invirase Hoffmann La-Roche, Inc.orporated c/o Genentech, Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -1.5MB) Statistical (PDF -1MB) PREA

Sarecycline – Seysara

Allergan, Inc.  Medical (PDF -1MB)  None None PREA Secnidazole – SOLOSEC  Lupin Pharmaceuticals, Inc. Medical (PDF 4 1MB)  None None PREA

Secukinuma – Cosentyx 

Novartis Pharmaceuticals Corporation Medical (PDF – 6 MB)  None None PREA Selegiline – Emsam Somerset Pharmaceuticals Medical (PDF -1.1MB)

Medical 2 (PDF -1.2MB)

Medical Secondary 1 (PDF -349KB)

Medical Secondary 2 (PDF -188KB)

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 Serdexmethylphenidate chloride (SDX Cl) & Dexmethylphenidate hydrochloride (d-MPH HCL) – Azstarys Commave Therapeutics SA Multidisciplinary (PDF – 6 MB) None None PREA Sevelamer Carbonate – Renvela Genzyme/Sanofi Medical (PDF – 745KB) Clinical pharmacology (PDF –  542KB) 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 – 6MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -508KB) BOTH 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 Spinosad – Natroba ParaPRO, LLC Medical (PDF – 854KB) 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 K) None None PREA Sofosbuvir and velpatasvir – Epclusa Gilead Sciences, Inc. Medical (PDF –  218 K) Clinical pharmacology (PDF – 511 KB) None PREA Sofosbuvir and velpatasvir – Epclusa  Gilead Sciences, Inc. Medical (PDF –  287 KB) Clinical pharmacology (PDF – 4 MB) None BPCA Solifenacin succinate – VESIcare Astellas Pharma Global Development, Inc. Medical (PDF – 2 MB) Clinical pharmacology (PDF – 933KB) Statistical (PDF – 960 KB) PREA Solifenacin succinate – VESIcare Astellas Pharma Global Development, Inc. Medical (PDF – 3MB)

CDTL (PDF – 1.1MB)

Clinical pharmacology (PDF -2MB) Statistical (PDF – 960 KB) PREA 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 – 5.1MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -792KB) PREA Sulfur Hexafluoride Lipid-Type A Microspheres – Lumason Bracco Diagnostics, Inc. Medical (PDF – 3MB)

CDTL (PDF – 1.1MB)

Clinical pharmacology (PDF – 1MB) Statistical (PDF – 859KB) PREA Sulfur Hexafluoride Lipid-Type A Microspheres – Lumason  Bracco Diagnostics, Inc. Medical (PDF -1.8MB) Clinical pharmacology (PDF -2.8MB) Statistical (PDF -843KB) 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) BPCA Sumatriptan/Naproxen – Treximet Pernix Therapeutics Medical (PDF -1.8MB) Clinical pharmacology (PDF -2.8MB) Statistical (PDF -843KB)

Statistical Addendum (PDF -702KB)

BPCA Sunitinib malate – Sutent  C.P. Pharmaceuticals International C.V. CDTL (PDF – 680 KB) None  None PREA 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 – 1.4MB) None BPCA Tavaborole – Kerydin  Anacor Pharmaceuticals, Inc. Multi-disciplinary review (PDF – 2.5 MB) None None PREA Tazarotene – Aralzo 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 BPCA Technetium 99m Tilmanocept – Lymphoseek Cardinal Health 414, LLC Multidisciplinary (PDF – 2.2MB) None None PREA Tedizolid phosphate – Sivextro  Cubist Pharmaceuticals, LLC Medical (PDF – 9 MB) None None PREA Teduglutide – Gattex Shire-NPS Pharmaceuticals, Inc. Medical (PDF – 9 MB) None None BOTH Tenofovir disoproxil fumarate – Viread Gilead Sciences Medical (PDF – 2.4MB) Clinical pharmacology (PDF – 1.4MB) Statistical (PDF – 1.4MB) PREA Tenofovir disoproxil fumarate – Viread Gilead Sciences   CDTL (PDF – 873 KB) Clinical pharmacology (PDF – 180 KB) Statistical (PDF – 149 KB)  PREA Tenofovir disoproxil fumarate – Viread Gilead Sciences CDTL (PDF – 349 KB) Clinical pharmacology (PDF –  1.7 MB) Statistical (PDF –  148 KB)  PREA Teriflunomide – Aubagio  Sanofi

CTDL (PDF – 3.3MB)

Clinical (PDF – 3.4MB)

Clinical pharmacology (PDF – 1.5MB) Statistical (PDF – 410KB) BOTH Tetracaine hydrochloride – None Alcon Research, Ltd. DD Medical Summary  (PDF -1.8MB)

Medical (PDF -1.4MB)

Clinical pharmacology (PDF – 158KB) Statistical (PDF – 2.3MB) PREA Tetracaine HCl and Oxymetazoline HCl – Kovanaze  St. Renatus, LLC Medical (PDF – 11.8MB) Clinical pharmacology (PDF – 11.6MB) Statistical (PDF – 2.4MB) PREA

Tezepelumab -Tezspir 

AstraZeneca Medical (PDF –  10 MB) None None PREA Ticagrelor – Brilinta NEW
  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 – 418KB

Clinical pharmacology (PDF – 5.9MB) Statistical (PDF – 1.3MB)

Statistical Addendum (PDF -327 KB)

PREA Tiotropium bromide – Spiriva Respimat  Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF –  4.8MB) Clinical pharmacology (PDF – 2MB) Statistical (PDF – 432K B) PREA Tobramycin 300 mg/4mL inhalation solution – Bethkis Cornerstone Therapeutics Medical (PDF – 5.4MB) Clinical pharmacology (PDF – 78KB) 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 PREA Tofacitinib – Xeljanz Pfizer, Inc. Medical (PDF – 8 MB) None None PREA Topiramate – Topamax Janssen Pharmaceuticals, Inc. Medical (PDF – 8.6MB) None Statistical (PDF – 881KB) PREA

Topiramate – Eprontia 

Azurity Pharmaceuticals, Inc. Medical (PDF – 669 KB) Clinical pharmacology  (PDF –  565 KB) None PREA Trabectedin – Yondelis Janssen Products, LP Medical (PDF – 2.5 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 – Multrys  American Regent, Inc. Medical (PDF – 321 MB) None None PREA Tranexamic acid – Lysteda Ferring Pharmaceuticals, Inc. None Clinical pharmacology (PDF – 1.2MB) 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 – Akli Galderma Research and Development, LLC Medical (PDF –  3 MB) None None PREA Upadacitinib – Rinvoq  AbbVie Inc. Medical (PDF –  10 MB) None None PREA Ustekinumab – Stelara Janssen Biotech, Inc. Medical (PDF –  352 MB) Clinical pharmacology (PDF – 3 MB) None PREA Valganciclovir hydrochloride – Valcyte Roche Palo Alto LLC c/o Genentech, Inc.orporated Medical (PDF -2 .7MB) Clinical pharmacology (PDF – 6MB) 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 PREA  Vilazodone hydrochloride – Viibryd  Allergan Sales, LLC Medical (PDF – 3 MB) None None BPCA

Vortioxetine – Trintellix 

Takeda Pharmaceuticals, USA, Inc. Medical (PDF – 3 MB) None None PREA Ustekinumab – Stelara Janssen Biotech Inc.

CDTL (PDF – 593 KB)

Medical (PDF – 5.2 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 Voriconazole – Vfend PF PRISM C.V.

Medical (PDF –  2 MB)

Medical PDF –  200 KB)

Clinical Pharmacology (PDF – 1 MB) Statistical (PDF –  200 KB) PREA Zepatier (elbasvir and grazoprevir)  Merck Sharpe & Dohme Corp Medical (PDF – 838 KB) Clinical Pharmacology (PDF – 272 KB)   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 -4.5MB) None Statistical (PDF -2.9MB) PREA

prea.pdf’>prea.pdf

Fonte/Source: http://www.fda.gov/drugs/development-resources/reviews-pediatric-studies-conducted-under-bpca-and-prea-2012-present