As of April 2014, FDA has approved the 25 NDA applications and 5 BLA applications.
Tuesday, 29 April 2014
FDA: Drugs Approved in January 2014: NDA Drugs
| "Drug Name and FDA Appl. #" | Active Ingredients | Company | Approval Date |
| FARXIGA (NDA #202293) | DAPAGLIFLOZIN | ASTRAZENECA AB | 1/8/2014 |
| PENNSAID (NDA #204623) | DICLOFENAC SODIUM | MALLINCKRODT INC | 1/16/2014 |
| ALEVE PM (NDA #205352) | DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM | BAYER HLTHCARE | 1/16/2014 |
| DECITABINE (NDA #205582) | DECITABINE | SUN PHARMA GLOBAL | 1/23/2014 |
| DESVENLAFAXINE FUMARATE (NDA #205583) | DESVENLAFAXINE FUMARATE | SUN PHARMA GLOBAL | 1/28/2014 |
| HETLIOZ (NDA #205677) | TASIMELTEON | VANDA PHARMS INC | 1/31/2014 |
Source:FDA
FDA: Drugs Approved in February: NDA Drugs
| "Drug Name and FDA Appl. #" | Active Ingredients | Company | Approval Date |
| IMBRUVICA (NDA #205552) | IBRUTINIB | PHARMACYCLICS INC | 2/12/2014 |
| VIMIZIM (BLA #125460) | ELOSULFASE ALFA | BIOMARIN PHARM | 2/14/2014 |
| NORTHERA (NDA #203202) | DROXIDOPA | CHELSEA THERAPS INC | 2/18/2014 |
| MYALEPT (BLA #125390) | METRELEPTIN | AMYLIN PHARMS LLC | 2/24/2014 |
| TIVORBEX (NDA #204768) | INDOMETHACIN | IROKO PHARMS LLC | 2/24/2014 |
Source: FDA
FDA: Drugs Approved in March: NDA Drugs
| "Drug Name and FDA Appl. #" | Active Ingredients | Company | Approval Date |
| AVEED (NDA #022219) | TESTOSTERONE UNDECANOATE | ENDO PHARMS INC | 3/5/2014 |
| XARTEMIS XR (NDA #204031) | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | MALLINCKRODT INC | 3/11/2014 |
| QUDEXY XR (NDA #205122) | TOPIRAMATE | UPSHER SMITH | 3/11/2014 |
| DOCETAXEL (NDA #202356) | DOCETAXEL | PFIZER LABS | 3/13/2014 |
| NOXAFIL (NDA #205596) | POSACONAZOLE | MERCK SHARP DOHME | 3/13/2014 |
| HEMANGEOL (NDA #205410) | PROPRANOLOL HYDROCHLORIDE | PIERRE FABRE DERMA | 3/14/2014 |
| NEURACEQ (NDA #204677) | FLORBETABEN F-18 | PIRAMAL IMAGING | 3/19/2014 |
| IMPAVIDO (NDA #204684) | MILTEFOSINE | PALADIN THERAP | 3/19/2014 |
| OTEZLA (NDA #205437) | APREMILAST | CELGENE CORP | 3/21/2014 |
| METRONIDAZOLE (NDA #205223) | METRONIDAZOLE | VALEANT PHARM NORTH | 3/24/2014 |
| NEXIUM 24HR (NDA #204655) | ESOMEPRAZOLE MAGNESIUM | ASTRAZENECA LP | 3/28/2014 |
Source:FDA
FDA: Drugs Approved in April 2014: NDA Drug Approvals
| Drug Name and FDA Appl. # | Active Ingredients | NDA Chem. Type * | Review Classifi- cation ** | Company | Approval Date |
|---|---|---|---|---|---|
| EVZIO (NDA # 205787) | NALOXONE HYDROCHLORIDE | 3 | KALEO INC. | 04/03/2014 | |
| TANZEUM (BLA # 125431) | ALBIGLUTIDE | GLAXOSMITHKLINE LLC | 04/15/2014 | ||
| VASOSTRICT (NDA # 204485) | VASOPRESSIN | 7 | PAR STERILE PRODUCTS LLC | 04/17/2014 | |
| CYRAMZA (BLA # 125477) | RAMUCIRUMAB | ELI LILLY AND CO | 04/21/2014 | ||
| SYLVANT (BLA # 125496) | SILTUXIMAB | JANSSEN BIOTECH | 04/22/2014 | ||
| CHEMET (NDA # 019998) | SUCCIMER | 1 | P, O | RECORDATI RARE | 04/23/2014 |
| OMTRYG (NDA # 204977) | OMEGA-3 ACID ETHYL ESTERS A | 5 | TRYGG PHARMA INC | 04/23/2014 | |
| PURIXAN (NDA # 205919) | MERCAPTOPURINE | 5 | NOVA LABORATORIES | 04/28/2014 |
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