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calendar

32,221 catalysts · 12,718 approval · 5,000 device 510k · 4,728 grant · 2,984 8k filing · 2,000 device pma · 2,000 device recall

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  • approval12,718
  • device 510k5,000
  • grant4,728
  • 8k filing2,984
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings572
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Dec 2, 2013

    3
    ›Dec 6, 2013approval4630d agoDEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) — FDA approvalMallinckrodt LLC

    Sponsor: IMPAX LABS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 6, 2013approval4630d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Dec 7, 2013approval4629d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

    Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

    full page →fda approvals ↗

    Week of Dec 9, 2013

    12
    ›Dec 10, 2013approval4626d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

    Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Dec 10, 2013approval

    Week of Dec 16, 2013

    9
    ›Dec 17, 2013approval4619d agoJUXTAPID (LOMITAPIDE MESYLATE) — FDA approvalChiesi USA Inc

    Sponsor: CHIESI. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 18, 2013approval

    Week of Dec 23, 2013

    15
    ›Dec 23, 2013approval4613d agoFOSAMAX (ALENDRONATE SODIUM) — FDA approvalALENDRONATE SODIUM

    Sponsor: ORGANON. Form: TABLET. Route: ORAL

    full page →ALENDRONATE SODIUM →fda approvals ↗
    ›Dec 23, 2013approval

    Week of Dec 30, 2013

    5
    ›Dec 30, 2013approval4606d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

    Sponsor: TARO. Form: TABLET. Route: ORAL

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

    Week of Jan 6, 2014

    6
    ›Jan 7, 2014approval4598d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Jan 7, 2014approval
    ← prev
    page 11 of 645
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    4626d ago
    XELODA (CAPECITABINE) — FDA approvalArmas Pharmaceuticals Inc

    Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 12, 2013approval4624d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Dec 12, 2013approval4624d agoDOXIL (LIPOSOMAL) (DOXORUBICIN HYDROCHLORIDE) — FDA approvalDoxil

    Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE, LIPOSOMAL. Route: INJECTION

    full page →Doxil →fda approvals ↗
    ›Dec 12, 2013approval4624d agoQUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

    Sponsor: NEXTWAVE. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 12, 2013approval4624d agoFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) — FDA approvaldexmethylphenidate hydrochloride ER

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

    full page →dexmethylphenidate hydrochloride ER →fda approvals ↗
    ›Dec 12, 2013approval4624d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Dec 13, 2013approval4623d agoEPIPEN E Z PEN (EPINEPHRINE) — FDA approvaladrenaline

    Sponsor: VIATRIS. Form: INJECTABLE. Route: INTRAMUSCULAR

    full page →adrenaline →fda approvals ↗
    ›Dec 13, 2013approval4623d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

    full page →fda approvals ↗
    ›Dec 13, 2013approval4623d agoMEN'S ROGAINE (MINOXIDIL) — FDA approvalVeradermics, Inc

    Sponsor: KENVUE BRANDS. Form: AEROSOL, FOAM. Route: TOPICAL

    full page →fda approvals ↗
    ›Dec 13, 2013approval4623d agoMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE CD

    Sponsor: AYTU BIOPHARMA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →METADATE CD →fda approvals ↗
    ›Dec 13, 2013approval4623d agoRITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalRITALIN LA

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

    full page →RITALIN LA →fda approvals ↗
    4618d ago
    GADAVIST (GADOBUTROL) — FDA approval

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

    full page →fda approvals ↗
    ›Dec 19, 2013approval4617d agoHALDOL (HALOPERIDOL DECANOATE) — FDA approvalJanssen Therapeutics

    Sponsor: JANSSEN PHARMS. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Dec 20, 2013approval4616d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

    Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Dec 20, 2013approval4616d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Dec 20, 2013approval4616d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

    Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Dec 20, 2013approval4616d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Dec 20, 2013approval4616d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Dec 20, 2013approval4616d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    4613d ago
    BINOSTO (ALENDRONATE SODIUM) — FDA approvalOrganon & Co.

    Sponsor: RADIUS. Form: TABLET, EFFERVESCENT. Route: ORAL

    full page →fda approvals ↗
    ›Dec 23, 2013approval4613d agoWELLBUTRIN SR (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Dec 23, 2013approval4613d agoWELLBUTRIN SR (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Dec 23, 2013approval4613d agoWELLBUTRIN (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Dec 23, 2013approval4613d agoWELLBUTRIN (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Dec 24, 2013approval4612d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

    Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

    full page →ondansetron hydrochloride CR →fda approvals ↗
    ›Dec 24, 2013approval4612d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

    Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

    full page →ondansetron hydrochloride CR →fda approvals ↗
    ›Dec 24, 2013approval4612d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalondansetron hydrochloride CR

    Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

    full page →ondansetron hydrochloride CR →fda approvals ↗
    ›Dec 24, 2013approval4612d 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, 2013approval4610d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

    Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

    full page →dabrafenib mesylate ODT →fda approvals ↗
    ›Dec 26, 2013approval4610d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Dec 27, 2013approval4609d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

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

    full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 27, 2013approval4609d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

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

    full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 27, 2013approval4609d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

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

    full page →fda approvals ↗
    4606d 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, 2013approval4606d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Jan 3, 2014approval4602d agoNIZORAL ANTI-DANDRUFF (KETOCONAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: KRAMER. Form: SHAMPOO. Route: TOPICAL

    full page →fda approvals ↗
    ›Jan 3, 2014approval4602d agoPYRIDOSTIGMINE BROMIDE — FDA approvalBausch Health US LLC

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

    full page →fda approvals ↗
    4598d ago
    NOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

    Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Jan 7, 2014approval4598d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

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

    full page →naltrexone ER →fda approvals ↗
    ›Jan 8, 2014approval4597d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Jan 9, 2014approval4596d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

    Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

    full page →dabrafenib mesylate ODT →fda approvals ↗
    ›Jan 9, 2014approval4596d agoMORPHINE SULFATE — FDA approvalKapanol

    Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

    full page →Kapanol →fda approvals ↗
    $OGN13.60+0.37%
    $KVUE19.23+0.26%
    $RDHL0.7390+6.64%
    $RDHL0.7390+6.64%
    $COLL29.47+1.24%
    $MANE114.39+5.28%
    $VTRS16.43+0.86%
    $VERX11.94+3.20%
    $AYTU2.2300-0.89%
    $NVS156.33+1.37%
    $IGC0.2670+0.41%
    $OGN13.60+0.37%
    $ALKS49.17+1.65%
    $NVS156.33+1.37%
    $NVS156.33+1.37%