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calendar

10,188 catalysts · 9,841 approval · 5,000 device 510k · 4,728 grant · 2,604 8k filing · 2,000 device pma · 2,000 device recall

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type: approval×type: pdufa×from 2017-04-24×clear all
type
  • approval9,841
  • device 510k5,000
  • grant4,728
  • 8k filing2,604
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • pdufa347
  • earnings315
  • therapy area
    • Dermatology1
    • Infectious Disease1

    Week of Apr 24, 2017

    32
    ›Apr 24, 2017approval3388d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Imatinib Mesylate Shilpa →fda approvals ↗
    ›Apr 24, 2017approval3388d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

    Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION

    full page →RIFADIN →fda approvals ↗
    ›Apr 24, 2017approval3388d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

    Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

    full page →RIFATER →fda approvals ↗
    ›Apr 24, 2017approval3388d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

    Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL

    full page →RIFADIN →fda approvals ↗
    ›Apr 24, 2017approval3388d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

    Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

    full page →alirocumab →fda approvals ↗
    ›Apr 24, 2017approval3388d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

    full page →ALDACTAZIDE →fda approvals ↗
    ›Apr 25, 2017approval3387d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

    Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

    full page →nivolumab →fda approvals ↗
    ›Apr 25, 2017approval3387d agoVICTOZA (LIRAGLUTIDE) — FDA approvalSaxenda

    Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →Saxenda →fda approvals ↗
    ›Apr 26, 2017approval3386d agoSAXENDA (LIRAGLUTIDE) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Apr 26, 2017approval3386d agoSAXENDA (LIRAGLUTIDE) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Apr 26, 2017approval3386d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 26, 2017approval3386d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 26, 2017approval3386d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 26, 2017approval3386d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 26, 2017approval3386d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 26, 2017approval3386d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 26, 2017approval3386d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 26, 2017approval3386d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 26, 2017approval3386d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 26, 2017approval3386d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 27, 2017approval3385d agoKETALAR (KETAMINE HYDROCHLORIDE) — FDA approvalPar Pharmaceutical Inc

    Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Apr 27, 2017approval3385d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

    Sponsor: PH HEALTH. Form: FOR SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Apr 27, 2017approval3385d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

    Sponsor: LUNDBECK PHARMS LLC. Form: TABLET. Route: ORAL

    full page →VIGABATRIN →fda approvals ↗
    ›Apr 27, 2017approval3385d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

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

    full page →VIGABATRIN →fda approvals ↗
    ›Apr 27, 2017approval3385d agoSTIVARGA (REGORAFENIB) — FDA approvalBayer AG

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

    full page →fda approvals ↗
    ›Apr 27, 2017approval3385d agoDIPRIVAN (PROPOFOL) — FDA approvalPROPOFOL

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

    full page →PROPOFOL →fda approvals ↗
    ›Apr 28, 2017approval3384d agoEPIPEN E Z PEN (EPINEPHRINE) — FDA approvaladrenaline

    Sponsor: VIATRIS. Form: INJECTABLE. Route: INTRAMUSCULAR

    full page →adrenaline →fda approvals ↗
    ›Apr 28, 2017approval3384d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

    Sponsor: ABBVIE INC. Form: VIAL

    full page →adalimumab →fda approvals ↗
    ›Apr 28, 2017approval3384d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗
    ›Apr 28, 2017approval3384d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

    Sponsor: HIKMA. Form: SYRUP. Route: ORAL

    full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗
    ›Apr 28, 2017approval3384d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Apr 28, 2017approval3384d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

    Week of May 1, 2017

    17
    ›May 1, 2017approval3381d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

    Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›May 2, 2017approval

    Week of May 8, 2017

    1
    ›May 9, 2017approval3373d agoLANSOPRAZOLE — FDA approvallansoprazole DR

    Sponsor: DEXCEL. Form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE. Route: ORAL

    full page →lansoprazole DR →fda approvals ↗
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    page 1 of 204
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    3380d ago
    CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →CLEOCIN →fda approvals ↗
    ›May 2, 2017approval3380d agoCLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →CLEOCIN →fda approvals ↗
    ›May 2, 2017approval3380d agoCLEOCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) — FDA approvalclindamycin hydrochloride

    Sponsor: PFIZER. Form: CAPSULE. Route: ORAL

    full page →clindamycin hydrochloride →fda approvals ↗
    ›May 2, 2017approval3380d agoCLEOCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) — FDA approvalclindamycin hydrochloride

    Sponsor: PFIZER. Form: CAPSULE. Route: ORAL

    full page →clindamycin hydrochloride →fda approvals ↗
    ›May 2, 2017approval3380d agoCLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →CLEOCIN →fda approvals ↗
    ›May 2, 2017approval3380d agoCLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →CLEOCIN →fda approvals ↗
    ›May 2, 2017approval3380d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›May 2, 2017approval3380d agoMEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (MEPERIDINE HYDROCHLORIDE) — FDA approvalHikma Pharmaceuticals Plc

    Sponsor: WEST-WARD PHARMS INT. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›May 3, 2017approval3379d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

    Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

    full page →blinatumomab →fda approvals ↗
    ›May 4, 2017approval3378d agoPRED MILD (PREDNISOLONE ACETATE) — FDA approvalprednisolone acetate

    Sponsor: ABBVIE. Form: SUSPENSION/DROPS. Route: OPHTHALMIC

    full page →prednisolone acetate →fda approvals ↗
    ›May 4, 2017approval3378d agoWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›May 4, 2017approval3378d agoCONTRAVE (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›May 4, 2017approval3378d agoWELLBUTRIN SR (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›May 4, 2017approval3378d agoFORFIVO XL (BUPROPION HYDROCHLORIDE) — FDA approvalTWi Pharmaceuticals Inc

    Sponsor: TWI PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›May 4, 2017approval3378d agoAPLENZIN (BUPROPION HYDROBROMIDE) — FDA approvalBausch Health US LLC

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

    full page →fda approvals ↗
    ›May 4, 2017approval3378d agoWELLBUTRIN (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    $NVS156.15-1.45%
    $BMY65.31+0.69%
    $ABBV250.94-2.51%
    $REGN762.63+3.29%
    $NVO47.08-8.78%
    $AZN169.64-0.99%
    $VTRS17.56-1.13%
    $PFE25.01+0.40%
    $PFE25.01+0.40%
    $PFE25.01+0.40%
    $PFE25.01+0.40%
    $AMGN385.16-0.64%
    $PFE25.01+0.40%
    $ABBV250.94-2.51%
    $PFE25.01+0.40%