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calendar

9,871 catalysts · 9,524 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: pdufa×type: approval×from 2017-08-31×clear all
type
  • approval9,524
  • 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 Aug 28, 2017

    5
    ›Aug 31, 2017approval3259d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

    Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL

    full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
    ›Aug 31, 2017approval3259d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

    Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL

    full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
    ›Aug 31, 2017approval3259d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

    Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL

    full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
    ›Aug 31, 2017approval3259d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

    Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL

    full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
    ›Aug 31, 2017approval3259d agoFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) — FDA approvalParatek Pharmaceuticals Inc

    Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

    full page →fda approvals ↗

    Week of Sep 4, 2017

    7
    ›Sep 5, 2017approval3254d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

    Sponsor: ACTELION. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 5, 2017approval

    Week of Sep 11, 2017

    6
    ›Sep 11, 2017approval3248d agoANTARA (MICRONIZED) (FENOFIBRATE) — FDA approvalFENOFIBRATE

    Sponsor: LUPIN. Form: CAPSULE. Route: ORAL

    full page →FENOFIBRATE →fda approvals ↗
    ›Sep 14, 2017approval

    Week of Sep 18, 2017

    9
    ›Sep 18, 2017approval3241d agoBUPROPION HYDROCHLORIDE — FDA approvalInvaGen Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Sep 19, 2017approval

    Week of Sep 25, 2017

    9
    ›Sep 25, 2017approval3234d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: LANNETT CO INC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Sep 25, 2017approval

    Week of Oct 2, 2017

    5
    ›Oct 5, 2017approval3224d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Oct 5, 2017approval

    Week of Oct 9, 2017

    3
    ›Oct 13, 2017approval3216d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

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

    full page →fda approvals ↗
    ›Oct 13, 2017approval

    Week of Oct 16, 2017

    5
    ›Oct 17, 2017approval3212d agoHIBICLENS (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

    Sponsor: MOLNLYCKE HLTH. Form: SOLUTION. Route: TOPICAL

    full page →fda approvals ↗
    ›Oct 19, 2017approval

    Week of Oct 23, 2017

    1
    ›Oct 23, 2017approval3206d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

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

    full page →fda approvals ↗
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    3254d ago
    TRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

    Sponsor: ACTELION. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Sep 6, 2017approval3253d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›Sep 6, 2017approval3253d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Imatinib Mesylate Shilpa →fda approvals ↗
    ›Sep 7, 2017approval3252d agoACTIQ (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: CEPHALON. Form: TROCHE/LOZENGE. Route: TRANSMUCOSAL

    full page →fda approvals ↗
    ›Sep 7, 2017approval3252d agoFENTORA (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Sep 8, 2017approval3251d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

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

    full page →fda approvals ↗
    3245d ago
    ALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

    Sponsor: BAYER. Form: TABLET. Route: ORAL

    full page →NAPROXEN SODIUM →fda approvals ↗
    ›Sep 14, 2017approval3245d agoDYNA-HEX 4 (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

    Sponsor: XTTRIUM. Form: SOLUTION. Route: TOPICAL

    full page →fda approvals ↗
    ›Sep 14, 2017approval3245d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

    Sponsor: IMMUNEX. Form: SYRINGE

    full page →fda approvals ↗
    ›Sep 15, 2017approval3244d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

    Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Sep 15, 2017approval3244d agoDYNA-HEX 2 (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

    Sponsor: XTTRIUM. Form: SOLUTION. Route: TOPICAL

    full page →fda approvals ↗
    3240d ago
    SUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: INDIVIOR. Form: FILM. Route: BUCCAL, SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Sep 19, 2017approval3240d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: INDIVIOR. Form: FILM. Route: BUCCAL, SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Sep 19, 2017approval3240d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalPrinston Pharmaceutical Inc

    Sponsor: UNICHEM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 20, 2017approval3239d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

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

    full page →alirocumab →fda approvals ↗
    ›Sep 22, 2017approval3237d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Sep 22, 2017approval3237d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›Sep 22, 2017approval3237d agoTEMOZOLOMIDE — FDA approvalAreva Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Sep 22, 2017approval3237d agoTRAVATAN Z (TRAVOPROST) — FDA approvalTRAVOPROST

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

    full page →TRAVOPROST →fda approvals ↗
    3234d ago
    NEOSTIGMINE METHYLSULFATE — FDA approvalNEOSTIGMINE METHYLSULFATE

    Sponsor: AMPHASTAR PHARMS INC. Form: SOLUTION. Route: INTRAVENOUS

    full page →NEOSTIGMINE METHYLSULFATE →fda approvals ↗
    ›Sep 28, 2017approval3231d agoSOLIQUA 100/33 (INSULIN GLARGINE) — FDA approvalToujeo LA

    Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →Toujeo LA →fda approvals ↗
    ›Sep 28, 2017approval3231d agoDOXYCYCLINE — FDA approvalZydus Therapeutics Inc

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

    full page →fda approvals ↗
    ›Sep 29, 2017approval3230d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

    full page →ALDACTAZIDE →fda approvals ↗
    ›Sep 29, 2017approval3230d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

    Sponsor: AMNEAL PHARMS NY. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Sep 29, 2017approval3230d agoAFREZZA (INSULIN RECOMBINANT HUMAN) — FDA approvalinsulin human

    Sponsor: MANNKIND. Form: POWDER. Route: INHALATION

    full page →insulin human →fda approvals ↗
    ›Sep 29, 2017approval3230d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Imatinib Mesylate Shilpa →fda approvals ↗
    ›Sep 29, 2017approval3230d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    3224d ago
    DEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Oct 5, 2017approval3224d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

    Sponsor: ABBVIE. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →divalproex sodium DR →fda approvals ↗
    ›Oct 5, 2017approval3224d agoCOMETRIQ (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

    Sponsor: EXELIXIS. Form: CAPSULE. Route: ORAL

    full page →cabozantinib s-malate →fda approvals ↗
    ›Oct 6, 2017approval3223d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

    Sponsor: IMMUNEX. Form: SYRINGE

    full page →fda approvals ↗
    3216d ago
    BUTRANS (BUPRENORPHINE) — FDA approvalBUTRANS

    Sponsor: PURDUE PHARMA LP. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

    full page →BUTRANS →fda approvals ↗
    ›Oct 15, 2017approval3214d agoMEPRON (ATOVAQUONE) — FDA approvalatovaquone

    Sponsor: GLAXOSMITHKLINE LLC. Form: SUSPENSION. Route: ORAL

    full page →atovaquone →fda approvals ↗
    3210d ago
    TYVASO (TREPROSTINIL) — FDA approvalUNITED THERAPEUTICS Corp

    Sponsor: UNITED THERAP. Form: SOLUTION. Route: INHALATION

    full page →fda approvals ↗
    ›Oct 20, 2017approval3209d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

    Sponsor: ACTELION. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 20, 2017approval3209d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

    Sponsor: ACTELION. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Oct 20, 2017approval3209d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

    Sponsor: PADAGIS US. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    $JNJ256.35+0.21%
    $ABBV250.94-2.51%
    $AMGN385.16-0.64%
    $NVS156.15-1.45%
    $NVS156.15-1.45%
    $BMY65.31+0.69%
    $INDV40.10-2.17%
    $REGN762.63+3.29%
    $BMY65.31+0.69%
    $INDV40.10-2.17%
    $NVS156.15-1.45%
    $AMPH19.94-2.16%
    $MNKD3.9100-4.87%
    $ABBV250.94-2.51%
    $ABBV250.94-2.51%
    $EXEL53.03-5.25%
    $AMGN385.16-0.64%
    $UTHR517.71-1.54%