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18,993 catalysts · 18,987 approval · 5,347 phase readout · 5,000 device 510k · 4,728 grant · 2,603 8k filing · 2,000 device pma

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  • approval18,987
  • phase readout5,347
  • device 510k5,000
  • grant4,728
  • 8k filing2,603
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area
    • Ophthalmology5

    Week of May 25, 2009

    4
    ›May 27, 2009approval6275d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Imatinib Mesylate Shilpa →fda approvals ↗
    ›May 27, 2009approval6275d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

    Sponsor: MEITHEAL. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›May 29, 2009approval6273d agoRECLAST (ZOLEDRONIC ACID) — FDA approvalZOLEDRONIC ACID

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

    full page →ZOLEDRONIC ACID →fda approvals ↗
    ›May 29, 2009approval6273d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗

    Week of Jun 1, 2009

    3
    ›Jun 1, 2009approval6270d agoPRIFTIN (RIFAPENTINE) — FDA approvalrifapentine

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

    full page →rifapentine →fda approvals ↗
    ›Jun 1, 2009approval

    Week of Jun 8, 2009

    2
    ›Jun 11, 2009approval6260d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

    Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Jun 12, 2009approval

    Week of Jun 15, 2009

    2
    ›Jun 17, 2009approval6254d agoOZURDEX (DEXAMETHASONE) — FDA approvaldexamethasone LA

    Sponsor: ABBVIE. Form: IMPLANT. Route: INTRAVITREAL

    full page →dexamethasone LA →fda approvals ↗
    ›Jun 19, 2009approval

    Week of Jun 22, 2009

    3
    ›Jun 23, 2009approval6248d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

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

    full page →fda approvals ↗
    ›Jun 24, 2009approval

    Week of Jun 29, 2009

    11
    ›Jun 30, 2009approval6241d agoPROMETRIUM (PROGESTERONE) — FDA approvalIBSA Institut Biochimique SA

    Sponsor: ACERTIS PHARMS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Jun 30, 2009approval

    Week of Jul 6, 2009

    2
    ›Jul 8, 2009approval6233d agoNICOTINE POLACRILEX — FDA approvalPL Developments Copiague LLC

    Sponsor: P AND L. Form: GUM, CHEWING. Route: BUCCAL

    full page →fda approvals ↗
    ›Jul 9, 2009approval

    Week of Jul 13, 2009

    5
    ›Jul 14, 2009approval6227d agoNAPROXEN SODIUM — FDA approvalNAPROXEN SODIUM

    Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL

    full page →NAPROXEN SODIUM →fda approvals ↗
    ›Jul 15, 2009approval

    Week of Jul 20, 2009

    4
    ›Jul 20, 2009approval6221d agoDIGOXIN — FDA approvalHikma Pharmaceuticals USA Inc

    Sponsor: IMPAX LABS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jul 22, 2009approval

    Week of Jul 27, 2009

    2
    ›Jul 28, 2009approval6213d agoFLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

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

    full page →fda approvals ↗
    ›Jul 30, 2009approval

    Week of Aug 3, 2009

    3
    ›Aug 3, 2009approval6207d agoPONSTEL (MEFENAMIC ACID) — FDA approvalAvion Pharmaceuticals LLC

    Sponsor: AVION PHARMS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Aug 7, 2009approval

    Week of Aug 17, 2009

    4
    ›Aug 18, 2009approval6192d agoGLYCOPYRROLATE — FDA approvalFresenius Kabi USA LLC

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

    full page →fda approvals ↗
    ›Aug 20, 2009approval

    Week of Aug 24, 2009

    2
    ›Aug 27, 2009approval6183d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

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

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
    ›Aug 27, 2009

    Week of Aug 31, 2009

    3
    ›Aug 31, 2009approval6179d agoZYPREXA ZYDIS (OLANZAPINE) — FDA approvalDR REDDYS LABORATORIES LTD

    Sponsor: CHEPLAPHARM. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →fda approvals ↗
    ›Aug 31, 2009approval
    ← prev
    page 104 of 380
    next →
    6270d ago
    TRIAMCINOLONE ACETONIDE — FDA approvaltriamcinolone acetonide Rising

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

    full page →triamcinolone acetonide Rising →fda approvals ↗
    ›Jun 1, 2009approval6270d agoROPINIROLE HYDROCHLORIDE — FDA approvalropinirole hydrochloride ER

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

    full page →ropinirole hydrochloride ER →fda approvals ↗
    6259d ago
    BENAZEPRIL HYDROCHLORIDE — FDA approvalBENAZEPRIL HYDROCHLORIDE

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

    full page →BENAZEPRIL HYDROCHLORIDE →fda approvals ↗
    6252d ago
    SALONPAS (MENTHOL) — FDA approvalHisamitsu America Inc

    Sponsor: HISAMITSU PHARM CO. Form: PATCH. Route: TOPICAL

    full page →fda approvals ↗
    6247d ago
    MEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

    Sponsor: GENUS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jun 24, 2009approval6247d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: ABBVIE ENDOCRINE INC. Form: POWDER. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    6241d ago
    REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) — FDA approvalANI PHARMACEUTICALS INC

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

    full page →fda approvals ↗
    ›Jun 30, 2009approval6241d agoREGLAN (METOCLOPRAMIDE HYDROCHLORIDE) — FDA approvalmetoclopramide hydrochloride

    Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

    full page →metoclopramide hydrochloride →fda approvals ↗
    ›Jul 1, 2009approval6240d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

    Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

    full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗
    ›Jul 1, 2009approval6240d agoWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jul 1, 2009approval6240d agoWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jul 1, 2009approval6240d agoWELLBUTRIN SR (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Jul 1, 2009approval6240d agoWELLBUTRIN SR (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Jul 1, 2009approval6240d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: APOTEX. Form: TABLET. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Jul 1, 2009approval6240d agoWELLBUTRIN (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Jul 1, 2009approval6240d agoWELLBUTRIN (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    6232d ago
    SUMATRIPTAN SUCCINATE — FDA approvalTonix Pharmaceuticals Holding Corp.

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

    full page →fda approvals ↗
    6226d ago
    DEPO-SUBQ PROVERA 104 (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

    Sponsor: PFIZER. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →medroxyprogesterone acetate →fda approvals ↗
    ›Jul 16, 2009approval6225d agoCODEINE SULFATE — FDA approvalcodeine

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →codeine →fda approvals ↗
    ›Jul 16, 2009approval6225d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

    Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

    full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗
    ›Jul 19, 2009approval6222d agoHALDOL (HALOPERIDOL DECANOATE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    6219d ago
    PAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

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

    full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗
    ›Jul 23, 2009approval6218d agoACTONEL (RISEDRONATE SODIUM) — FDA approvalAllergan Finance LLC

    Sponsor: APIL. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jul 23, 2009approval6218d agoCETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE) — FDA approvalCETIRIZINE HYDROCHLORIDE

    Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL

    full page →CETIRIZINE HYDROCHLORIDE →fda approvals ↗
    6211d ago
    TYVASO (TREPROSTINIL) — FDA approvalUNITED THERAPEUTICS Corp

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

    full page →fda approvals ↗
    6203d ago
    TRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

    Sponsor: ACTELION. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Aug 7, 2009approval6203d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

    Sponsor: ACTELION. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    6190d ago
    LEVETIRACETAM — FDA approvalAprecia Pharmaceuticals LLC

    Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Aug 21, 2009approval6189d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

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

    full page →VIGABATRIN →fda approvals ↗
    ›Aug 21, 2009approval6189d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

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

    full page →VIGABATRIN →fda approvals ↗
    approval
    6183d ago
    PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

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

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
    6179d ago
    ZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

    Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Aug 31, 2009approval6179d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

    Sponsor: CHEPLAPHARM. Form: POWDER. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    $NVS156.15-1.45%
    $CPIX6.6800-0.74%
    $ABBV250.94-2.51%
    $RDY11.85+0.17%
    $AMRX18.32-0.97%
    $ANIP79.24-1.48%
    $TNXP10.01-0.79%
    $PFE25.01+0.40%
    $UTHR517.71-1.54%
    $TEVA35.01-1.13%
    $TEVA35.01-1.13%