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calendar

30,531 catalysts · 11,000 approval · 5,000 device 510k · 4,728 grant · 3,012 8k filing · 2,000 device pma · 2,000 device recall

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type
  • approval11,000
  • device 510k5,000
  • grant4,728
  • 8k filing3,012
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings577
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Oct 26, 2015

    9
    ›Oct 28, 2015approval3940d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    ›Oct 28, 2015approval3940d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    ›Oct 28, 2015approval3940d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    ›Oct 28, 2015approval3940d agoROPINIROLE HYDROCHLORIDE — FDA approvalropinirole hydrochloride ER

    Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL

    full page →ropinirole hydrochloride ER →fda approvals ↗
    ›Oct 29, 2015approval3939d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

    Sponsor: PHARMOBEDIENT. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Oct 30, 2015approval3938d agoCEREZYME (IMIGLUCERASE) — FDA approvalimiglucerase

    Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION

    full page →imiglucerase →fda approvals ↗
    ›Oct 30, 2015approval3938d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

    Sponsor: PH HEALTH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 30, 2015approval3938d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Oct 31, 2015approval3937d agoMOMETASONE FUROATE — FDA approvalFougera Pharmaceuticals Inc

    Sponsor: FOUGERA PHARMS. Form: OINTMENT. Route: TOPICAL

    full page →fda approvals ↗

    Week of Nov 2, 2015

    16
    ›Nov 2, 2015approval3935d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

    Sponsor: NOVARTIS. Form: INJECTABLE. Route: INJECTION

    full page →Restasis →fda approvals ↗
    ›Nov 2, 2015approval

    Week of Nov 9, 2015

    20
    ›Nov 9, 2015approval3928d agoCEFEPIME AND DEXTROSE IN DUPLEX CONTAINER (CEFEPIME HYDROCHLORIDE) — FDA approvalSamson Medical Technologies LLC

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

    full page →fda approvals ↗
    ›Nov 9, 2015approval

    Week of Nov 16, 2015

    5
    ›Nov 16, 2015approval3921d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Nov 17, 2015approval
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    3935d ago
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Nov 3, 2015approval3934d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

    Sponsor: LUNDBECK PHARMS LLC. Form: FOR SOLUTION. Route: ORAL

    full page →VIGABATRIN →fda approvals ↗
    ›Nov 3, 2015approval3934d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Nov 3, 2015approval3934d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Nov 3, 2015approval3934d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Nov 4, 2015approval3933d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: ACTAVIS MID ATLANTIC. Form: SOLUTION. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Nov 5, 2015approval3932d agoIOPIDINE (APRACLONIDINE HYDROCHLORIDE) — FDA approvalHARROW, INC.

    Sponsor: HARROW EYE. Form: SOLUTION/DROPS. Route: OPHTHALMIC

    full page →fda approvals ↗
    ›Nov 5, 2015approval3932d agoOLANZAPINE — FDA approvalolanzapine ODT

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

    full page →olanzapine ODT →fda approvals ↗
    ›Nov 5, 2015approval3932d agoOLANZAPINE — FDA approvalolanzapine ODT

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

    full page →olanzapine ODT →fda approvals ↗
    ›Nov 5, 2015approval3932d agoOLANZAPINE — FDA approvalolanzapine ODT

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

    full page →olanzapine ODT →fda approvals ↗
    ›Nov 5, 2015approval3932d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

    full page →fda approvals ↗
    ›Nov 5, 2015approval3932d agoANASTROZOLE — FDA approvalANASTROZOLE

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →ANASTROZOLE →fda approvals ↗
    ›Nov 5, 2015approval3932d agoANASTROZOLE — FDA approvalANASTROZOLE

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →ANASTROZOLE →fda approvals ↗
    ›Nov 6, 2015approval3931d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

    Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

    full page →enzalutamide →fda approvals ↗
    ›Nov 6, 2015approval3931d agoIRBESARTAN — FDA approvalIRBESARTAN

    Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL

    full page →IRBESARTAN →fda approvals ↗
    3928d ago
    FOLLISTIM AQ (FOLLITROPIN ALFA/BETA) — FDA approvalfollitropin beta

    Sponsor: ORGANON USA LLC. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →follitropin beta →fda approvals ↗
    ›Nov 9, 2015approval3928d agoTEMOZOLOMIDE — FDA approvalAreva Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Nov 9, 2015approval3928d agoTRAMADOL HYDROCHLORIDE — FDA approvalSenores Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Nov 9, 2015approval3928d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

    Sponsor: TEVA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 9, 2015approval3928d agoFENTANYL CITRATE — FDA approvalEffentora

    Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

    full page →Effentora →fda approvals ↗
    ›Nov 9, 2015approval3928d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

    Sponsor: NOVEN PHARMS INC. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

    full page →fda approvals ↗
    ›Nov 10, 2015approval3927d agoQOLIANA (BRIMONIDINE TARTRATE) — FDA approvalLumify

    Sponsor: SANDOZ. Form: SOLUTION/DROPS. Route: OPHTHALMIC

    full page →Lumify →fda approvals ↗
    ›Nov 10, 2015approval3927d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Nov 10, 2015approval3927d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Nov 12, 2015approval3925d agoDEXMETHYLPHENIDATE HYDROCHLORIDE — FDA approvaldexmethylphenidate hydrochloride ER

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

    full page →dexmethylphenidate hydrochloride ER →fda approvals ↗
    ›Nov 12, 2015approval3925d agoBENAZEPRIL HYDROCHLORIDE — FDA approvalBENAZEPRIL HYDROCHLORIDE

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

    full page →BENAZEPRIL HYDROCHLORIDE →fda approvals ↗
    ›Nov 12, 2015approval3925d agoOXYCONTIN (OXYCODONE HYDROCHLORIDE) — FDA approvalOXYCODONE HYDROCHLORIDE

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

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Nov 13, 2015approval3924d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

    full page →POSACONAZOLE →fda approvals ↗
    ›Nov 13, 2015approval3924d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

    full page →POSACONAZOLE →fda approvals ↗
    ›Nov 13, 2015approval3924d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

    Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Nov 13, 2015approval3924d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

    Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Nov 13, 2015approval3924d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

    Sponsor: MERCK SHARP DOHME. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →POSACONAZOLE →fda approvals ↗
    ›Nov 13, 2015approval3924d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

    Sponsor: MERCK SHARP DOHME. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →POSACONAZOLE →fda approvals ↗
    ›Nov 13, 2015approval3924d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

    Sponsor: APOTEX. Form: TABLET. Route: ORAL

    full page →tramadol hydrochloride ER →fda approvals ↗
    3920d ago
    LEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

    Sponsor: SANDOZ. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›Nov 18, 2015approval3919d agoNARCAN (NALOXONE HYDROCHLORIDE) — FDA approvalEmergent Devices Inc

    Sponsor: EMERGENT. Form: SPRAY, METERED. Route: NASAL

    full page →fda approvals ↗
    ›Nov 19, 2015approval3918d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

    Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
    ›Nov 20, 2015approval3917d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Spexotras →fda approvals ↗
    $NVS156.33+1.37%
    $NVS156.33+1.37%
    $NVS156.33+1.37%
    $HROW40.03-1.01%