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calendar

18,993 catalysts · 18,987 approval · 5,720 phase readout · 5,000 device 510k · 4,728 grant · 2,952 8k filing · 2,000 device pma

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  • approval18,987
  • phase readout5,720
  • device 510k5,000
  • grant4,728
  • 8k filing2,952
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • earnings409
  • therapy area
    • Ophthalmology5

    Week of Dec 23, 2013

    6
    ›Dec 24, 2013approval4609d 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, 2013approval4607d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

    Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

    full page →dabrafenib mesylate ODT →fda approvals ↗
    ›Dec 26, 2013approval4607d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Dec 27, 2013approval4606d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

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

    full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 27, 2013approval4606d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

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

    full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 27, 2013approval4606d 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, 2013approval4603d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

    Sponsor: TARO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 30, 2013approval

    Week of Jan 6, 2014

    7
    ›Jan 7, 2014approval4595d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Jan 7, 2014approval

    Week of Jan 13, 2014

    15
    ›Jan 13, 2014approval4589d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

    Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

    full page →taliglucerase alfa →fda approvals ↗
    ›Jan 14, 2014approval

    Week of Jan 20, 2014

    6
    ›Jan 21, 2014approval4581d agoPERCODAN (ASPIRIN) — FDA approvalEndo Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jan 21, 2014approval

    Week of Jan 27, 2014

    5
    ›Jan 29, 2014approval4573d agoTOPAMAX SPRINKLE (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Jan 29, 2014approval

    Week of Feb 3, 2014

    6
    ›Feb 4, 2014approval4567d agoOXYCONTIN (OXYCODONE HYDROCHLORIDE) — FDA approvalOXYCODONE HYDROCHLORIDE

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

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Feb 5, 2014approval
    ← prev
    page 137 of 380
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    4603d ago
    DIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Dec 30, 2013approval4603d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Jan 3, 2014approval4599d agoNIZORAL ANTI-DANDRUFF (KETOCONAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: KRAMER. Form: SHAMPOO. Route: TOPICAL

    full page →fda approvals ↗
    ›Jan 3, 2014approval4599d agoPYRIDOSTIGMINE BROMIDE — FDA approvalBausch Health US LLC

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

    full page →fda approvals ↗
    4595d ago
    NOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

    Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Jan 7, 2014approval4595d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

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

    full page →naltrexone ER →fda approvals ↗
    ›Jan 8, 2014approval4594d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Jan 9, 2014approval4593d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

    Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

    full page →dabrafenib mesylate ODT →fda approvals ↗
    ›Jan 9, 2014approval4593d agoMORPHINE SULFATE — FDA approvalKapanol

    Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

    full page →Kapanol →fda approvals ↗
    ›Jan 9, 2014approval4593d agoVANTAS (HISTRELIN ACETATE) — FDA approvalEndo Pharmaceuticals Inc

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

    full page →fda approvals ↗
    4588d ago
    CALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

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

    full page →fda approvals ↗
    ›Jan 14, 2014approval4588d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

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

    full page →fda approvals ↗
    ›Jan 14, 2014approval4588d agoDOVONEX (CALCIPOTRIENE) — FDA approvalcalcipotriene

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

    full page →calcipotriene →fda approvals ↗
    ›Jan 15, 2014approval4587d 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, 2014approval4586d agoSTALEVO 75 (CARBIDOPA) — FDA approvalcarbidopa

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

    full page →carbidopa →fda approvals ↗
    ›Jan 16, 2014approval4586d agoEOVIST (GADOXETATE DISODIUM) — FDA approval

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

    full page →fda approvals ↗
    ›Jan 16, 2014approval4586d agoNUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

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

    full page →tapentadol hydrochloride ER →fda approvals ↗
    ›Jan 16, 2014approval4586d agoNUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

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

    full page →tapentadol hydrochloride ER →fda approvals ↗
    ›Jan 16, 2014approval4586d 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, 2014approval4586d agoOXAYDO (OXYCODONE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: ZYLA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jan 16, 2014approval4586d agoTEGRETOL-XR (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

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

    full page →carbamazepine ER →fda approvals ↗
    ›Jan 16, 2014approval4586d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Jan 16, 2014approval4586d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

    Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Jan 17, 2014approval4585d agoALDACTAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: PFIZER. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    4581d ago
    METHYLIN ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETHYLIN ER

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

    full page →METHYLIN ER →fda approvals ↗
    ›Jan 22, 2014approval4580d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

    Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

    full page →Restasis →fda approvals ↗
    ›Jan 23, 2014approval4579d 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, 2014approval4578d agoHUMATROPE (SOMATROPIN) — FDA approvalEMD Serono Inc

    Sponsor: LILLY. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Jan 24, 2014approval4578d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

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

    full page →fda approvals ↗
    4573d ago
    TOPAMAX (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Jan 30, 2014approval4572d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Jan 31, 2014approval4571d agoOXYCONTIN (OXYCODONE HYDROCHLORIDE) — FDA approvalOXYCODONE HYDROCHLORIDE

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

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Jan 31, 2014approval4571d agoSALONPAS (MENTHOL) — FDA approvalHisamitsu America Inc

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

    full page →fda approvals ↗
    4566d ago
    PYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

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

    full page →fda approvals ↗
    ›Feb 7, 2014approval4564d agoOZURDEX (DEXAMETHASONE) — FDA approvaldexamethasone LA

    Sponsor: ABBVIE. Form: IMPLANT. Route: INTRAVITREAL

    full page →dexamethasone LA →fda approvals ↗
    ›Feb 7, 2014approval4564d agoAMMONIA N 13 (AMMONIA N-13) — FDA approval

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

    full page →fda approvals ↗
    ›Feb 7, 2014approval4564d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Feb 7, 2014approval4564d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    $NVS154.21-0.15%
    $PFE26.20+1.51%
    $COLL31.11-12.95%
    $COLL31.11-12.95%
    $IGC0.2670+0.41%
    $RDHL0.7390+6.64%
    $ORN12.42-2.13%
    $NVS154.21-0.15%
    $CPIX7.6800+1.72%
    $NVS154.21-0.15%
    $ALKS49.53+1.10%
    $COLL31.11-12.95%
    $PFE26.20+1.51%
    $NVS154.21-0.15%
    $ABBV243.87-0.95%
    $AMRX18.25-1.14%
    $NVS154.21-0.15%
    $NVS154.21-0.15%
    $NVS154.21-0.15%