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calendar

25,822 catalysts · 16,936 approval · 3,617 device 510k · 2,351 grant · 1,087 device recall · 1,069 device pma · 762 recall

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  • approval16,936
  • device 510k3,617
  • grant2,351
  • device recall1,087
  • device pma1,069
  • recall762
therapy area

no tagged catalysts yet

Week of Dec 23, 2013

6
›Dec 24, 2013approval4632d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalondansetron hydrochloride CR

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →ondansetron hydrochloride CR →fda approvals ↗
›Dec 26, 2013approval4630d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗
›Dec 26, 2013approval4630d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Dec 27, 2013approval4629d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA USA. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗
›Dec 27, 2013approval4629d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA USA. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗
›Dec 27, 2013approval4629d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Week of Dec 30, 2013

5
›Dec 30, 2013approval4626d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

Sponsor: TARO. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Dec 30, 2013approval4626d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Dec 30, 2013approval4626d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Jan 3, 2014approval4622d agoNIZORAL ANTI-DANDRUFF (KETOCONAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: KRAMER. Form: SHAMPOO. Route: TOPICAL

full page →fda approvals ↗
›Jan 3, 2014approval4622d agoPYRIDOSTIGMINE BROMIDE — FDA approvalBausch Health US LLC

Sponsor: US ARMY. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Week of Jan 6, 2014

7
›Jan 7, 2014approval4618d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗
›Jan 7, 2014approval4618d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Jan 7, 2014approval4618d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

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

full page →naltrexone ER →fda approvals ↗
›Jan 8, 2014approval4617d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗
›Jan 9, 2014approval4616d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗
›Jan 9, 2014approval4616d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →Kapanol →fda approvals ↗
›Jan 9, 2014approval4616d agoVANTAS (HISTRELIN ACETATE) — FDA approvalEndo Pharmaceuticals Inc

Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS

full page →fda approvals ↗

Week of Jan 13, 2014

15
›Jan 13, 2014approval4612d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

full page →taliglucerase alfa →fda approvals ↗
›Jan 14, 2014approval4611d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗
›Jan 14, 2014approval4611d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

Sponsor: EDENBRIDGE PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗
›Jan 14, 2014approval4611d agoDOVONEX (CALCIPOTRIENE) — FDA approvalcalcipotriene

Sponsor: LEO PHARMA AS. Form: CREAM. Route: TOPICAL

full page →calcipotriene →fda approvals ↗
›Jan 15, 2014approval4610d agoHEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM) — FDA approvalHEPARIN SODIUM

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →HEPARIN SODIUM →fda approvals ↗
›Jan 16, 2014approval4609d agoSTALEVO 75 (CARBIDOPA) — FDA approvalcarbidopa

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

full page →carbidopa →fda approvals ↗
›Jan 16, 2014approval4609d agoEOVIST (GADOXETATE DISODIUM) — FDA approval

Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗
›Jan 16, 2014approval4609d agoNUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

Sponsor: COLLEGIUM PHARM INC. Form: TABLET. Route: ORAL

full page →tapentadol hydrochloride ER →fda approvals ↗
›Jan 16, 2014approval4609d agoNUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

Sponsor: COLLEGIUM PHARM INC. Form: SOLUTION. Route: ORAL

full page →tapentadol hydrochloride ER →fda approvals ↗
›Jan 16, 2014approval4609d agoNUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

Sponsor: COLLEGIUM PHARM INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tapentadol hydrochloride ER →fda approvals ↗
›Jan 16, 2014approval4609d agoOXAYDO (OXYCODONE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: ZYLA. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Jan 16, 2014approval4609d agoTEGRETOL-XR (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗
›Jan 16, 2014approval4609d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →carbamazepine ER →fda approvals ↗
›Jan 16, 2014approval4609d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

full page →carbamazepine ER →fda approvals ↗
›Jan 17, 2014approval4608d agoALDACTAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Week of Jan 20, 2014

6
›Jan 21, 2014approval4604d agoPERCODAN (ASPIRIN) — FDA approvalEndo Pharmaceuticals Inc

Sponsor: ENDO OPERATIONS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Jan 21, 2014approval4604d agoMETHYLIN ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETHYLIN ER

Sponsor: SPECGX LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METHYLIN ER →fda approvals ↗
›Jan 22, 2014approval4603d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

full page →Restasis →fda approvals ↗
›Jan 23, 2014approval4602d agoDEXMETHYLPHENIDATE HYDROCHLORIDE — FDA approvaldexmethylphenidate hydrochloride ER

Sponsor: AUROLIFE PHARMA LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗
›Jan 24, 2014approval4601d agoHUMATROPE (SOMATROPIN) — FDA approvalEMD Serono Inc

Sponsor: LILLY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Jan 24, 2014approval4601d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Week of Jan 27, 2014

5
›Jan 29, 2014approval4596d agoTOPAMAX SPRINKLE (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗
›Jan 29, 2014approval4596d agoTOPAMAX (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗
›Jan 30, 2014approval4595d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Jan 31, 2014approval4594d agoOXYCONTIN (OXYCODONE HYDROCHLORIDE) — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Jan 31, 2014approval4594d agoSALONPAS (MENTHOL) — FDA approvalHisamitsu America Inc

Sponsor: HISAMITSU PHARM CO. Form: PATCH. Route: TOPICAL

full page →fda approvals ↗

Week of Feb 3, 2014

6
›Feb 4, 2014approval4590d agoOXYCONTIN (OXYCODONE HYDROCHLORIDE) — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Feb 5, 2014approval4589d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

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

full page →fda approvals ↗
›Feb 7, 2014approval4587d agoOZURDEX (DEXAMETHASONE) — FDA approvaldexamethasone LA

Sponsor: ABBVIE. Form: IMPLANT. Route: INTRAVITREAL

full page →dexamethasone LA →fda approvals ↗
›Feb 7, 2014approval4587d agoAMMONIA N 13 (AMMONIA N-13) — FDA approval

Sponsor: WA UNIV SCH MED. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗
›Feb 7, 2014approval4587d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
›Feb 7, 2014approval4587d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
← prev
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$IGC0.2670+0.41%
$ALKS47.41-3.05%
$RDHL0.7390+6.64%
$PFE27.96-0.21%
$NVS153.81-0.54%
$NVS153.81-0.54%
$NVS153.81-0.54%
$NVS153.81-0.54%
$AMRX17.54-2.61%
$CPIX8.4600-2.20%
$NVS153.81-0.54%
$COLL25.35-4.12%
$COLL25.35-4.12%
$COLL25.35-4.12%
$ORN12.42-2.13%
$PFE27.96-0.21%
$NVS153.81-0.54%
$NVS153.81-0.54%
$ABBV255.48-1.03%