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calendar

28,263 catalysts · 17,815 approval · 4,115 device 510k · 2,475 grant · 1,585 device recall · 1,367 device pma · 906 recall

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  • approval17,815
  • device 510k4,115
  • grant2,475
  • device recall1,585
  • device pma1,367
  • recall906
therapy area

no tagged catalysts yet

Week of Aug 25, 2014

10
›Aug 25, 2014approval4388d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗
›Aug 25, 2014approval4388d agoMEMBRANEBLUE (TRYPAN BLUE) — FDA approval

Sponsor: DORC. Form: SOLUTION. Route: OPHTHALMIC

full page →fda approvals ↗
›Aug 27, 2014approval4386d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

full page →taliglucerase alfa →fda approvals ↗
›Aug 27, 2014approval4386d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

full page →taliglucerase alfa →fda approvals ↗
›Aug 28, 2014approval4385d agoSTAVZOR (VALPROIC ACID) — FDA approvalVALPROIC ACID

Sponsor: BIONPHARMA. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗
›Aug 28, 2014approval4385d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: RHODES PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Aug 29, 2014approval4384d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

Sponsor: ALKERMES. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →naltrexone ER →fda approvals ↗
›Aug 29, 2014approval4384d agoFENTORA (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TABLET. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗
›Aug 29, 2014approval4384d agoCLEOCIN (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: SWAB. Route: TOPICAL

full page →CLEOCIN →fda approvals ↗
›Aug 29, 2014approval4384d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

full page →fda approvals ↗

Week of Sep 1, 2014

9
›Sep 2, 2014approval4380d agoIBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: AVET LIFESCIENCES. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗
›Sep 2, 2014approval4380d agoIBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗
›Sep 2, 2014approval4380d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: MYLAN. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗
›Sep 3, 2014approval4379d agoDIGOXIN — FDA approvalDIGOXIN

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →DIGOXIN →fda approvals ↗
›Sep 4, 2014approval4378d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →pembrolizumab →fda approvals ↗
›Sep 4, 2014approval4378d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Sep 4, 2014approval4378d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Sep 4, 2014approval4378d agoANTARA (MICRONIZED) (FENOFIBRATE) — FDA approvalFENOFIBRATE

Sponsor: LUPIN. Form: CAPSULE. Route: ORAL

full page →FENOFIBRATE →fda approvals ↗
›Sep 5, 2014approval4377d agoCEREZYME (IMIGLUCERASE) — FDA approvalimiglucerase

Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION

full page →imiglucerase →fda approvals ↗

Week of Sep 8, 2014

11
›Sep 8, 2014approval4374d agoRINGER'S IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: OTSUKA ICU MEDCL. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Sep 8, 2014approval4374d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗
›Sep 9, 2014approval4373d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Sep 10, 2014approval4372d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

full page →enzalutamide →fda approvals ↗
›Sep 10, 2014approval4372d agoCONTRAVE (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

full page →fda approvals ↗
›Sep 11, 2014approval4371d agoCHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE) — FDA approvalAlgoTherapeutix SAS

Sponsor: TP ANDA HOLDINGS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Sep 11, 2014approval4371d agoCHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE) — FDA approvalAlgoTherapeutix SAS

Sponsor: TP ANDA HOLDINGS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Sep 11, 2014approval4371d agoTRAZODONE HYDROCHLORIDE — FDA approvalTRAZODONE HYDROCHLORIDE

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

full page →TRAZODONE HYDROCHLORIDE →fda approvals ↗
›Sep 11, 2014approval4371d agoTRAZODONE HYDROCHLORIDE — FDA approvalTRAZODONE HYDROCHLORIDE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →TRAZODONE HYDROCHLORIDE →fda approvals ↗
›Sep 12, 2014approval4370d agoHUMATROPE (SOMATROPIN) — FDA approvalEMD Serono Inc

Sponsor: LILLY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Sep 14, 2014approval4368d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA USA. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Week of Sep 15, 2014

11
›Sep 15, 2014approval4367d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Sep 15, 2014approval4367d agoMEMBRANEBLUE (TRYPAN BLUE) — FDA approval

Sponsor: DORC. Form: SOLUTION. Route: OPHTHALMIC

full page →fda approvals ↗
›Sep 15, 2014approval4367d agoIRBESARTAN — FDA approvalIRBESARTAN

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL

full page →IRBESARTAN →fda approvals ↗
›Sep 16, 2014approval4366d agoTEGRETOL-XR (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗
›Sep 16, 2014approval4366d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →carbamazepine ER →fda approvals ↗
›Sep 16, 2014approval4366d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

full page →carbamazepine ER →fda approvals ↗
›Sep 18, 2014approval4364d agoCLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗
›Sep 18, 2014approval4364d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

full page →dulaglutide →fda approvals ↗
›Sep 19, 2014approval4363d agoAMLODIPINE BESYLATE — FDA approvalGraviti Pharmaceuticals Inc

Sponsor: GRAVITI PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Sep 19, 2014approval4363d agoOTEZLA (APREMILAST) — FDA approvalapremilast

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

full page →apremilast →fda approvals ↗
›Sep 21, 2014approval4361d agoDOXYCYCLINE — FDA approvalPrasco LLC

Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Week of Sep 22, 2014

9
›Sep 22, 2014approval4360d agoLATANOPROST — FDA approvalXalatan

Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →Xalatan →fda approvals ↗
›Sep 22, 2014approval4360d agoMETHADOSE (METHADONE HYDROCHLORIDE) — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗
›Sep 22, 2014approval4360d agoIRBESARTAN — FDA approvalIRBESARTAN

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL

full page →IRBESARTAN →fda approvals ↗
›Sep 23, 2014approval4359d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

Sponsor: ABBVIE INC. Form: VIAL

full page →adalimumab →fda approvals ↗
›Sep 24, 2014approval4358d agoBUPROPION HYDROCHLORIDE — FDA approvalSenores Pharmaceuticals Inc

Sponsor: SENORES PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Sep 24, 2014approval4358d agoBUPROPION HYDROCHLORIDE — FDA approvalSenores Pharmaceuticals Inc

Sponsor: SENORES PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Sep 24, 2014approval4358d agoBUPROPION HYDROCHLORIDE — FDA approvalIpca Pharmaceuticals Inc

Sponsor: IMPAX LABS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗
›Sep 24, 2014approval4358d agoBUPROPION HYDROCHLORIDE — FDA approvalIpca Pharmaceuticals Inc

Sponsor: IMPAX LABS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗
›Sep 25, 2014approval4357d agoLOSARTAN POTASSIUM — FDA approvalAlembic Pharmaceuticals Inc

Sponsor: ALEMBIC PHARMS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗
← prev
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$RDY12.18+0.16%
$NVS153.81-0.54%
$AMRX17.54-2.61%
$IGC0.2670+0.41%
$ALKS47.41-3.05%
$PFE27.96-0.21%
$PFE27.96-0.21%
$RDY12.18+0.16%
$PFE27.96-0.21%
$NVS153.81-0.54%
$NVS153.81-0.54%
$NVS153.81-0.54%
$PFE27.96-0.21%
$LLY1174.61-0.13%
$AMGN432.42-1.05%
$ABBV255.48-1.03%