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18,993 catalysts · 18,987 approval · 5,443 phase readout · 5,000 device 510k · 4,728 grant · 2,667 8k filing · 2,000 device pma

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  • approval18,987
  • phase readout5,443
  • device 510k5,000
  • grant4,728
  • 8k filing2,667
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area
    • Ophthalmology5

    Week of Jul 30, 2012

    14
    ›Jul 30, 2012approval5118d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

    Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Aug 1, 2012approval5116d agoISOVUE-250 (IOPAMIDOL) — FDA approval

    Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Aug 1, 2012approval5116d agoISOVUE-370 (IOPAMIDOL) — FDA approval

    Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Aug 1, 2012approval5116d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Aug 1, 2012approval5116d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Aug 1, 2012approval5116d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Aug 1, 2012approval5116d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Aug 2, 2012approval5115d agoWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Aug 2, 2012approval5115d agoWELLBUTRIN SR (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Aug 2, 2012approval5115d agoWELLBUTRIN (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Aug 2, 2012approval5115d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

    Sponsor: UCB INC. Form: INJECTABLE. Route: INJECTION

    full page →certolizumab pegol →fda approvals ↗
    ›Aug 3, 2012approval5114d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

    Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Aug 3, 2012approval5114d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

    Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Aug 3, 2012approval5114d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

    Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →fda approvals ↗

    Week of Aug 6, 2012

    4
    ›Aug 9, 2012approval5108d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

    full page →ALDACTAZIDE →fda approvals ↗
    ›Aug 9, 2012approval

    Week of Aug 13, 2012

    4
    ›Aug 13, 2012approval5104d agoATELVIA (RISEDRONATE SODIUM) — FDA approvalAllergan Finance LLC

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

    full page →fda approvals ↗
    ›Aug 13, 2012approval

    Week of Aug 20, 2012

    2
    ›Aug 20, 2012approval5097d agoEPIPEN E Z PEN (EPINEPHRINE) — FDA approvaladrenaline

    Sponsor: VIATRIS. Form: INJECTABLE. Route: INTRAMUSCULAR

    full page →adrenaline →fda approvals ↗
    ›Aug 21, 2012approval

    Week of Aug 27, 2012

    11
    ›Aug 27, 2012approval5090d agoROPINIROLE HYDROCHLORIDE — FDA approvalElite Laboratories Inc

    Sponsor: CHARTWELL RX. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Aug 28, 2012approval

    Week of Sep 3, 2012

    4
    ›Sep 4, 2012approval5082d agoBOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

    Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 6, 2012approval

    Week of Sep 10, 2012

    3
    ›Sep 10, 2012approval5076d agoOMEPRAZOLE — FDA approvalomeprazole DR

    Sponsor: DEXCEL PHARMA. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →omeprazole DR →fda approvals ↗
    ›Sep 11, 2012approval

    Week of Sep 17, 2012

    4
    ›Sep 17, 2012approval5069d agoALDACTONE (SPIRONOLACTONE) — FDA approvalALDACTONE

    Sponsor: PFIZER. Form: TABLET. Route: ORAL

    full page →ALDACTONE →fda approvals ↗
    ›Sep 18, 2012approval

    Week of Sep 24, 2012

    4
    ›Sep 24, 2012approval5062d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

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

    full page →LOSARTAN POTASSIUM →fda approvals ↗
    ›Sep 27, 2012approval
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    page 124 of 380
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    5108d ago
    LEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

    Sponsor: MEITHEAL. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›Aug 10, 2012approval5107d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Aug 10, 2012approval5107d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    5104d ago
    ACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

    full page →tocilizumab →fda approvals ↗
    ›Aug 15, 2012approval5102d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

    Sponsor: SUN PHARM INDUSTRIES. Form: TABLET. Route: ORAL

    full page →IBANDRONATE SODIUM →fda approvals ↗
    ›Aug 15, 2012approval5102d agoAPLENZIN (BUPROPION HYDROBROMIDE) — FDA approvalBausch Health US LLC

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

    full page →fda approvals ↗
    5096d ago
    FLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

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

    full page →fda approvals ↗
    5089d ago
    KALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

    full page →fda approvals ↗
    ›Aug 28, 2012approval5089d agoGABAPENTIN — FDA approvalGABAPENTIN

    Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE. Route: ORAL

    full page →GABAPENTIN →fda approvals ↗
    ›Aug 28, 2012approval5089d agoNUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

    Sponsor: COLLEGIUM PHARM INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →tapentadol hydrochloride ER →fda approvals ↗
    ›Aug 29, 2012approval5088d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

    Sponsor: UCB INC. Form: INJECTABLE. Route: INJECTION

    full page →certolizumab pegol →fda approvals ↗
    ›Aug 30, 2012approval5087d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

    Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

    full page →Restasis →fda approvals ↗
    ›Aug 30, 2012approval5087d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

    Sponsor: NOVARTIS. Form: INJECTABLE. Route: INJECTION

    full page →Restasis →fda approvals ↗
    ›Aug 30, 2012approval5087d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

    Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

    full page →Restasis →fda approvals ↗
    ›Aug 30, 2012approval5087d agoLINZESS (LINACLOTIDE) — FDA approvallinaclotide

    Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

    full page →linaclotide →fda approvals ↗
    ›Aug 31, 2012approval5086d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

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

    full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗
    ›Aug 31, 2012approval5086d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

    Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

    full page →enzalutamide →fda approvals ↗
    5080d ago
    CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER (CEFEPIME HYDROCHLORIDE) — FDA approvalSamson Medical Technologies LLC

    Sponsor: B BRAUN. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Sep 6, 2012approval5080d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Sep 7, 2012approval5079d agoOZURDEX (DEXAMETHASONE) — FDA approvaldexamethasone LA

    Sponsor: ABBVIE. Form: IMPLANT. Route: INTRAVITREAL

    full page →dexamethasone LA →fda approvals ↗
    5075d ago
    ESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

    Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 12, 2012approval5074d agoAUBAGIO (TERIFLUNOMIDE) — FDA approvalteriflunomide

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

    full page →teriflunomide →fda approvals ↗
    5068d ago
    ZEGERID OTC (OMEPRAZOLE) — FDA approvalCovis Pharmaceuticals Inc (Inactive)

    Sponsor: RILEY CONSUMER. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Sep 19, 2012approval5067d agoDOXIL (LIPOSOMAL) (DOXORUBICIN HYDROCHLORIDE) — FDA approvalDoxil

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

    full page →Doxil →fda approvals ↗
    ›Sep 21, 2012approval5065d agoVENOFER (IRON SUCROSE) — FDA approvalInternational Medication Systems Ltd

    Sponsor: AM REGENT. Form: INJECTABLE. Route: INTRAVENOUS

    full page →fda approvals ↗
    5059d ago
    QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

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

    full page →fda approvals ↗
    ›Sep 27, 2012approval5059d agoSTIVARGA (REGORAFENIB) — FDA approvalBayer AG

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

    full page →fda approvals ↗
    ›Sep 27, 2012approval5059d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

    full page →ALDACTAZIDE →fda approvals ↗
    $PFE25.03+0.08%
    $VTRS17.63+0.40%
    $VERX13.40+3.80%
    $INDV40.10-2.17%
    $INDV40.10-2.17%
    $COLL35.58+0.54%
    $NVS153.67-1.59%
    $NVS153.67-1.59%
    $NVS153.67-1.59%
    $ABBV245.10-2.33%
    $COLL35.58+0.54%
    $ABBV245.10-2.33%
    $ABBV245.10-2.33%