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calendar

32,065 catalysts · 12,534 approval · 5,000 device 510k · 4,728 grant · 3,012 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2013-04-29×clear all

type

approval12,534
device 510k5,000
grant4,728
8k filing3,012
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings577

phase 2 completion172

therapy area

Oncology148
Infectious Disease46
Cardiology37
Immunology35
Dermatology31
Pulmonology22
Women's Health19
Ophthalmology16
Pain15

Week of May 5, 2014

›May 7, 2014approval4479d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›May 8, 2014approval4478d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗

›May 8, 2014approval4478d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗

›May 9, 2014approval4477d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Week of May 12, 2014

›May 12, 2014approval4474d agoZIRGAN (GANCICLOVIR) — FDA approvalganciclovir

Sponsor: BAUSCH AND LOMB. Form: GEL. Route: OPHTHALMIC

full page →ganciclovir →fda approvals ↗

›May 12, 2014approval

Week of May 19, 2014

›May 20, 2014approval4466d agoTYVASO (TREPROSTINIL) — FDA approvalUNITED THERAPEUTICS Corp

Sponsor: UNITED THERAP. Form: SOLUTION. Route: INHALATION

full page →fda approvals ↗

›May 20, 2014approval

Week of May 26, 2014

›May 28, 2014approval4458d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

Sponsor: LABS JUVISE. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›May 30, 2014approval

Week of Jun 2, 2014

›Jun 2, 2014approval4453d agoMETHADOSE (METHADONE HYDROCHLORIDE) — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: SPECGX LLC. Form: CONCENTRATE. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

›Jun 2, 2014approval

Week of Jun 9, 2014

›Jun 9, 2014approval4446d agoDULOXETINE HYDROCHLORIDE — FDA approvalduloxetine hydrochloride DR

Sponsor: ALEMBIC. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

full page →duloxetine hydrochloride DR →fda approvals ↗

›Jun 9, 2014approval

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page 11 of 642

4474d ago

HYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

Sponsor: ACTAVIS LABS FL INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›May 12, 2014approval4474d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›May 13, 2014approval4473d agoRECLAST (ZOLEDRONIC ACID) — FDA approvalZOLEDRONIC ACID

Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

full page →ZOLEDRONIC ACID →fda approvals ↗

›May 14, 2014approval4472d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

Sponsor: ABBVIE INC. Form: VIAL

full page →adalimumab →fda approvals ↗

›May 14, 2014approval4472d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

full page →taliglucerase alfa →fda approvals ↗

›May 14, 2014approval4472d agoMINOCYCLINE HYDROCHLORIDE — FDA approvalMINOCYCLINE HYDROCHLORIDE

Sponsor: TORRENT. Form: CAPSULE. Route: ORAL

full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗

›May 14, 2014approval4472d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›May 15, 2014approval4471d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›May 16, 2014approval4470d agoESTRING (ESTRADIOL) — FDA approvalestradiol ER

Sponsor: PFIZER. Form: INSERT, EXTENDED RELEASE. Route: VAGINAL

full page →estradiol ER →fda approvals ↗

›May 16, 2014approval4470d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›May 16, 2014approval4470d agoCHILDREN'S ZYRTEC HIVES (CETIRIZINE HYDROCHLORIDE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

4466d ago

ENTYVIO (VEDOLIZUMAB) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›May 21, 2014approval4465d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: FOSUN PHARMA. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›May 21, 2014approval4465d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: FOSUN PHARMA. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›May 21, 2014approval4465d agoFENTANYL CITRATE — FDA approvalEffentora

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →Effentora →fda approvals ↗

›May 22, 2014approval4464d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Imatinib Mesylate Shilpa →fda approvals ↗

›May 23, 2014approval4463d agoSODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (SODIUM CHLORIDE) — FDA approvalRevalesio Corp

Sponsor: B BRAUN. Form: SOLUTION. Route: IRRIGATION

full page →fda approvals ↗

›May 23, 2014approval4463d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

full page →enzalutamide →fda approvals ↗

4456d ago

ABILIFY MAINTENA KIT (ARIPIPRAZOLE) — FDA approvalaripiprazole LA

Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →aripiprazole LA →fda approvals ↗

›May 30, 2014approval4456d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

Sponsor: ABBVIE INC. Form: VIAL

full page →adalimumab →fda approvals ↗

4453d ago

OXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

›Jun 2, 2014approval4453d agoMS CONTIN (MORPHINE SULFATE) — FDA approvalKapanol

Sponsor: PURDUE PHARMA LP. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →Kapanol →fda approvals ↗

›Jun 2, 2014approval4453d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: GENUS LIFESCIENCES. Form: CAPSULE. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

›Jun 5, 2014approval4450d agoFIORICET W/ CODEINE (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: ACTAVIS LABS UT INC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Jun 5, 2014approval4450d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: INDIVIOR. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Jun 6, 2014approval4449d agoCEFEPIME AND DEXTROSE IN DUPLEX CONTAINER (CEFEPIME HYDROCHLORIDE) — FDA approvalSamson Medical Technologies LLC

Sponsor: B BRAUN. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Jun 6, 2014approval4449d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗

›Jun 6, 2014approval4449d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗

›Jun 8, 2014approval4447d agoDIPRIVAN (PROPOFOL) — FDA approvalPROPOFOL

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

full page →PROPOFOL →fda approvals ↗

4446d ago

DEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

›Jun 9, 2014approval4446d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

›Jun 9, 2014approval4446d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

›Jun 9, 2014approval4446d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

›Jun 9, 2014approval4446d agoPROSTIN VR PEDIATRIC (ALPROSTADIL) — FDA approvalalprostadil