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29,202 catalysts · 9,676 approval · 5,000 device 510k · 4,728 grant · 2,667 8k filing · 2,000 device pma · 2,000 device recall

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  • approval9,676
  • device 510k5,000
  • grant4,728
  • 8k filing2,667
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • pdufa347
  • earnings317
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Aug 28, 2017

    7
    ›Aug 29, 2017approval3262d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Aug 30, 2017approval3261d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

    full page →tocilizumab →fda approvals ↗
    ›Aug 31, 2017approval3260d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

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

    full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
    ›Aug 31, 2017approval3260d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

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

    full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
    ›Aug 31, 2017approval3260d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

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

    full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
    ›Aug 31, 2017approval3260d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

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

    full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
    ›Aug 31, 2017approval3260d 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, 2017approval3255d 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, 2017approval3249d 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, 2017approval3242d 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, 2017approval3235d 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, 2017approval3225d 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, 2017approval3217d 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

    4
    ›Oct 17, 2017approval3213d agoHIBICLENS (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

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

    full page →fda approvals ↗
    ›Oct 19, 2017approval
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    3255d ago
    TRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

    full page →fda approvals ↗
    ›Sep 6, 2017approval3254d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›Sep 6, 2017approval3254d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Imatinib Mesylate Shilpa →fda approvals ↗
    ›Sep 7, 2017approval3253d agoACTIQ (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Sep 7, 2017approval3253d agoFENTORA (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Sep 8, 2017approval3252d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

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

    full page →fda approvals ↗
    3246d ago
    ALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

    Sponsor: BAYER. Form: TABLET. Route: ORAL

    full page →NAPROXEN SODIUM →fda approvals ↗
    ›Sep 14, 2017approval3246d agoDYNA-HEX 4 (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

    Sponsor: XTTRIUM. Form: SOLUTION. Route: TOPICAL

    full page →fda approvals ↗
    ›Sep 14, 2017approval3246d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

    Sponsor: IMMUNEX. Form: SYRINGE

    full page →fda approvals ↗
    ›Sep 15, 2017approval3245d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

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

    full page →fda approvals ↗
    ›Sep 15, 2017approval3245d agoDYNA-HEX 2 (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

    Sponsor: XTTRIUM. Form: SOLUTION. Route: TOPICAL

    full page →fda approvals ↗
    3241d ago
    SUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Sep 19, 2017approval3241d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Sep 19, 2017approval3241d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalPrinston Pharmaceutical Inc

    Sponsor: UNICHEM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 20, 2017approval3240d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

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

    full page →alirocumab →fda approvals ↗
    ›Sep 22, 2017approval3238d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Sep 22, 2017approval3238d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›Sep 22, 2017approval3238d agoTEMOZOLOMIDE — FDA approvalAreva Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Sep 22, 2017approval3238d agoTRAVATAN Z (TRAVOPROST) — FDA approvalTRAVOPROST

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

    full page →TRAVOPROST →fda approvals ↗
    3235d ago
    NEOSTIGMINE METHYLSULFATE — FDA approvalNEOSTIGMINE METHYLSULFATE

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

    full page →NEOSTIGMINE METHYLSULFATE →fda approvals ↗
    ›Sep 28, 2017approval3232d agoSOLIQUA 100/33 (INSULIN GLARGINE) — FDA approvalToujeo LA

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

    full page →Toujeo LA →fda approvals ↗
    ›Sep 28, 2017approval3232d agoDOXYCYCLINE — FDA approvalZydus Therapeutics Inc

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

    full page →fda approvals ↗
    ›Sep 29, 2017approval3231d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

    full page →ALDACTAZIDE →fda approvals ↗
    ›Sep 29, 2017approval3231d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

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

    full page →fda approvals ↗
    ›Sep 29, 2017approval3231d agoAFREZZA (INSULIN RECOMBINANT HUMAN) — FDA approvalinsulin human

    Sponsor: MANNKIND. Form: POWDER. Route: INHALATION

    full page →insulin human →fda approvals ↗
    ›Sep 29, 2017approval3231d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Imatinib Mesylate Shilpa →fda approvals ↗
    ›Sep 29, 2017approval3231d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    3225d 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, 2017approval3225d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Oct 5, 2017approval3225d agoCOMETRIQ (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

    Sponsor: EXELIXIS. Form: CAPSULE. Route: ORAL

    full page →cabozantinib s-malate →fda approvals ↗
    ›Oct 6, 2017approval3224d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

    Sponsor: IMMUNEX. Form: SYRINGE

    full page →fda approvals ↗
    3217d ago
    BUTRANS (BUPRENORPHINE) — FDA approvalBUTRANS

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

    full page →BUTRANS →fda approvals ↗
    ›Oct 15, 2017approval3215d agoMEPRON (ATOVAQUONE) — FDA approvalatovaquone

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

    full page →atovaquone →fda approvals ↗
    3211d ago
    TYVASO (TREPROSTINIL) — FDA approvalUNITED THERAPEUTICS Corp

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

    full page →fda approvals ↗
    ›Oct 20, 2017approval3210d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

    Sponsor: ACTELION. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 20, 2017approval3210d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

    full page →fda approvals ↗
    $JNJ254.41-0.76%
    $ABBV245.10-2.33%
    $NVS153.67-1.59%
    $BMY65.47+0.24%
    $BMY65.47+0.24%
    $AMGN378.87-1.63%
    $NVS153.67-1.59%
    $REGN759.24-0.44%
    $INDV40.10-2.17%
    $INDV40.10-2.17%
    $AMPH20.02+0.40%
    $MNKD3.8000-2.81%
    $NVS153.67-1.59%
    $ABBV245.10-2.33%
    $ABBV245.10-2.33%
    $AMGN378.87-1.63%
    $EXEL55.06+3.83%
    $UTHR516.31-0.27%