HEALINE

Drug Approvals

Source: U.S. Food and Drug Administration

Updated: May 28, 2019

To view all recent drug appovals, click here.

May 28, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Revlimid
NDA #021880
Lenalidomide Capsule; Oral SUPPL-57 Celgene Efficacy Approved

May 24, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Dapagliflozin
ANDA #211156
Dapagliflozin Unknown ORIG-1 Inventia Hlthcare Tentative Approval
Jakafi
NDA #202192
Ruxolitinib Phosphate Tablet; Oral SUPPL-17 Incyte Corp Efficacy Approved
Pemetrexed Sodium
ANDA #208262
Pemetrexed Sodium Unknown ORIG-1 Wockhardt Bio Ag Tentative Approval
Piqray
NDA #212526
Alpelisib Tablet; Oral ORIG-1 Novartis Pharms Corp Type 1 - New Molecular Entity Approved

May 23, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Lyrica
NDA #021446
Pregabalin Capsule; Oral SUPPL-36 Pf Prism Cv Efficacy Approved
Lyrica
NDA #022488
Pregabalin Solution; Oral SUPPL-14 Pf Prism Cv Efficacy Approved
Pemetrexed Disodium
NDA #211090
Pemetrexed Disodium Unknown ORIG-1 Biocon Pharma Ltd Tentative Approval
Slynd
NDA #211367
Drospirenone Tablet; Oral ORIG-1 Exeltis Usa Inc Type 2 - New Active Ingredient and Type 3 - New Dosage Form Approved
Truxima
BLA #761088
Rituximab-Abbs Injectable; Injection SUPPL-1 Celltrion Inc Efficacy Approved
Truxima
BLA #761088
Rituximab-Abbs Injectable; Injection SUPPL-2 Celltrion Inc Efficacy Approved

May 22, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cyproheptadine Hydrochloride
ANDA #212423
Cyproheptadine Hydrochloride Syrup; Oral ORIG-1 Quagen Approved
Decitabine
NDA #205582
Decitabine Powder; Intravenous SUPPL-9 Sun Pharma Global Labeling Approved
Epidiolex
NDA #210365
Cannabidiol Solution; Oral SUPPL-4 Gw Res Ltd Manufacturing (CMC) Approved
Erlotinib
ANDA #211083
Erlotinib Unknown ORIG-1 Accord Hlthcare Inc Tentative Approval
Esomeprazole Magnesium
ANDA #206296
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral ORIG-1 Zydus Pharms Approved
Levofloxacin
ANDA #091678
Levofloxacin Solution; Oral SUPPL-4 Hi Tech Pharma Labeling Approved
Levofloxacin
ANDA #091678
Levofloxacin Solution; Oral SUPPL-4 Hi Tech Pharma Labeling Approved
Ofloxacin
ANDA #076093
Ofloxacin Tablet; Oral SUPPL-11 Larken Labs Labeling Approved
Ofloxacin
ANDA #076093
Ofloxacin Tablet; Oral SUPPL-11 Larken Labs Labeling Approved
Phytonadione
ANDA #207719
Phytonadione Injectable; Injection ORIG-1 Dr Reddys Labs Ltd Approved
Siklos
NDA #208843
Hydroxyurea Tablet; Oral SUPPL-2 Addmedica Sas Labeling Approved
Sotradecol
ANDA #040541
Sodium Tetradecyl Sulfate Injectable; Injection SUPPL-15 Mylan Institutional Labeling Approved
Sotradecol
ANDA #040541
Sodium Tetradecyl Sulfate Injectable; Injection SUPPL-15 Mylan Institutional Labeling Approved
Trientine Hydrochloride
ANDA #211134
Trientine Hydrochloride Capsule; Oral ORIG-1 Msn Labs Pvt Ltd Approved

May 21, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cleocin
NDA #050680
Clindamycin Phosphate Cream; Vaginal SUPPL-17 Pharmacia and Upjohn Labeling Approved
Dalfampridine
ANDA #208292
Dalfampridine Tablet, Extended Release; Oral ORIG-1 Sun Pharm Approved
Donepezil Hydrochloride
ANDA #077518
Donepezil Hydrochloride Tablet; Oral SUPPL-2 Cipla Ltd Labeling Approved
Donepezil Hydrochloride
ANDA #090056
Donepezil Hydrochloride Tablet; Oral SUPPL-10 Aurobindo Labeling Approved
Donepezil Hydrochloride
ANDA #090290
Donepezil Hydrochloride Tablet; Oral SUPPL-9 Sandoz Labeling Approved
Donepezil Hydrochloride
ANDA #201724
Donepezil Hydrochloride Tablet; Oral SUPPL-5 Alembic Pharms Ltd Labeling Approved
Donepezil Hydrochloride
ANDA #202723
Donepezil Hydrochloride Tablet; Oral SUPPL-4 Dr Reddys Labs Ltd Labeling Approved
Donepezil Hydrochloride
ANDA #202723
Donepezil Hydrochloride Tablet; Oral SUPPL-5 Dr Reddys Labs Ltd Labeling Approved
Donepezil Hydrochloride
ANDA #202723
Donepezil Hydrochloride Tablet; Oral SUPPL-5 Dr Reddys Labs Ltd Labeling Approved
Losartan Potassium
ANDA #202230
Losartan Potassium Tablet; Oral SUPPL-10 Macleods Pharms Ltd Labeling Approved
Losartan Potassium
ANDA #202230
Losartan Potassium Tablet; Oral SUPPL-10 Macleods Pharms Ltd Labeling Approved
Paricalcitol
ANDA #206699
Paricalcitol Solution; Intravenous SUPPL-1 Amneal Pharms Co Labeling Approved
Welchol
NDA #021176
Colesevelam Hydrochloride Tablet; Oral SUPPL-45 Daiichi Sankyo Labeling Approved
Welchol
NDA #022362
Colesevelam Hydrochloride For Suspension; Oral SUPPL-25 Daiichi Sankyo Labeling Approved
Yupelri
NDA #210598
Revefenacin Solution; Inhalation SUPPL-1 Mylan Ireland Ltd Labeling Approved

May 20, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Albendazole
ANDA #208094
Albendazole Tablet; Oral ORIG-1 Actavis Elizabeth Approved
Apokyn
NDA #021264
Apomorphine Hydrochloride Injectable; Subcutaneous SUPPL-16 Us Worldmeds Labeling Approved
Apokyn
NDA #021264
Apomorphine Hydrochloride Injectable; Subcutaneous SUPPL-16 Us Worldmeds Labeling Approved
Dactinomycin
ANDA #203999
Dactinomycin Injectable; Injection ORIG-1 X-Gen Pharms Inc Approved
Dimethyl Fumarate
ANDA #210492
Dimethyl Fumarate Unknown ORIG-1 Sun Pharm Inds Ltd Tentative Approval
Donepezil Hydrochloride
ANDA #090686
Donepezil Hydrochloride Tablet; Oral SUPPL-12 Torrent Pharms Labeling Approved
Donepezil Hydrochloride
ANDA #203656
Donepezil Hydrochloride Tablet; Oral SUPPL-1 Unichem Labs Ltd Labeling Approved
Donepezil Hydrochloride
ANDA #203656
Donepezil Hydrochloride Tablet; Oral SUPPL-1 Unichem Labs Ltd Labeling Approved
Donepezil Hydrochloride
ANDA #203656
Donepezil Hydrochloride Tablet; Oral SUPPL-1 Unichem Labs Ltd Labeling Approved
Donepezil Hydrochloride
ANDA #204609
Donepezil Hydrochloride Tablet; Oral SUPPL-2 Cadila Pharms Ltd Labeling Approved
Donepezil Hydrochloride
ANDA #204609
Donepezil Hydrochloride Tablet; Oral SUPPL-2 Cadila Pharms Ltd Labeling Approved
Faslodex
NDA #021344
Fulvestrant Injectable; Intramuscular SUPPL-39 Astrazeneca Labeling Approved
Faslodex
NDA #021344
Fulvestrant Injectable; Intramuscular SUPPL-39 Astrazeneca Labeling Approved
Fulvestrant
NDA #210326
Fulvestrant Injectable; Injection ORIG-1 Fresenius Kabi Usa Type 5 - New Formulation or New Manufacturer Approved
Methylprednisolone Acetate
ANDA #210043
Methylprednisolone Acetate Injectable; Injection ORIG-1 Amneal Pharms Co Approved
Solifenacin Succinate
ANDA #202551
Solifenacin Succinate Tablet; Oral ORIG-1 Watson Labs Inc Approved
Solifenacin Succinate
ANDA #205483
Solifenacin Succinate Tablet; Oral ORIG-1 Ajanta Pharma Ltd Approved
Solifenacin Succinate
ANDA #205575
Solifenacin Succinate Tablet; Oral ORIG-1 Alembic Pharms Ltd Approved
Solifenacin Succinate
ANDA #209239
Solifenacin Succinate Tablet; Oral ORIG-1 Glenmark Pharms Inc Approved
Solifenacin Succinate
ANDA #209333
Solifenacin Succinate Tablet; Oral ORIG-1 Qilu Pharm Co Ltd Approved
Solifenacin Succinate
ANDA #209719
Solifenacin Succinate Tablet; Oral ORIG-1 Amneal Pharms Co Approved
Solifenacin Succinate
ANDA #209818
Solifenacin Succinate Tablet; Oral ORIG-1 Breckenridge Pharm Approved
Solifenacin Succinate
ANDA #209839
Solifenacin Succinate Tablet; Oral ORIG-1 Cipla Approved
Solifenacin Succinate
ANDA #210224
Solifenacin Succinate Tablet; Oral ORIG-1 Alkem Labs Ltd Approved
Solifenacin Succinate
ANDA #210281
Solifenacin Succinate Tablet; Oral ORIG-1 Jiangxi Boya Seehot Approved
Solifenacin Succinate
ANDA #210582
Solifenacin Succinate Tablet; Oral ORIG-1 Airis Pharma Pvt Ltd Approved
Solifenacin Succinate
ANDA #210688
Solifenacin Succinate Tablet; Oral ORIG-1 Msn Labs Pvt Ltd Approved
Solifenacin Succinate
ANDA #211657
Solifenacin Succinate Tablet; Oral ORIG-1 Sciegen Pharms Inc Approved

May 19, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Benazepril Hydrochloride
ANDA #076820
Benazepril Hydrochloride Tablet; Oral SUPPL-18 Amneal Pharms Labeling Approved
Letrozole
ANDA #090289
Letrozole Tablet; Oral SUPPL-4 Teva Pharms Labeling Approved
Letrozole
ANDA #090289
Letrozole Tablet; Oral SUPPL-5 Teva Pharms Labeling Approved
Letrozole
ANDA #091303
Letrozole Tablet; Oral SUPPL-2 Apotex Inc Labeling Approved
Letrozole
ANDA #091303
Letrozole Tablet; Oral SUPPL-3 Apotex Inc Labeling Approved
Letrozole
ANDA #091303
Letrozole Tablet; Oral SUPPL-2 Apotex Inc Labeling Approved
Letrozole
ANDA #091303
Letrozole Tablet; Oral SUPPL-3 Apotex Inc Labeling Approved
Letrozole
ANDA #202716
Letrozole Tablet; Oral SUPPL-3 Jiangsu Hengrui Med Labeling Approved
Letrozole
ANDA #202716
Letrozole Tablet; Oral SUPPL-2 Jiangsu Hengrui Med Labeling Approved
Letrozole
ANDA #202716
Letrozole Tablet; Oral SUPPL-3 Jiangsu Hengrui Med Labeling Approved
Mometasone Furoate
ANDA #076624
Mometasone Furoate Ointment; Topical SUPPL-8 Taro Labeling Approved

 

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