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calendar

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 Sep 24, 2012

    3
    ›Sep 27, 2012approval5059d agoIRBESARTAN — FDA approvalIRBESARTAN

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

    full page →IRBESARTAN →fda approvals ↗
    ›Sep 27, 2012approval5059d agoIRBESARTAN — FDA approvalIRBESARTAN

    Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL

    full page →IRBESARTAN →fda approvals ↗
    ›Sep 28, 2012approval5058d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

    Sponsor: ABBVIE INC. Form: VIAL

    full page →adalimumab →fda approvals ↗

    Week of Oct 1, 2012

    9
    ›Oct 2, 2012approval5054d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

    Sponsor: ACTELION. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 2, 2012approval

    Week of Oct 8, 2012

    6
    ›Oct 9, 2012approval5047d agoCAPRELSA (VANDETANIB) — FDA approvalvandetanib

    Sponsor: GENZYME CORP. Form: TABLET. Route: ORAL

    full page →vandetanib →fda approvals ↗
    ›Oct 11, 2012approval

    Week of Oct 15, 2012

    3
    ›Oct 15, 2012approval5041d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    ›Oct 15, 2012approval

    Week of Oct 29, 2012

    10
    ›Oct 29, 2012approval5027d agoTOPAMAX SPRINKLE (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Oct 29, 2012approval

    Week of Nov 5, 2012

    6
    ›Nov 5, 2012approval5020d agoSALONPAS (MENTHOL) — FDA approvalHisamitsu America Inc

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

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

    Week of Nov 12, 2012

    5
    ›Nov 13, 2012approval5012d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

    Sponsor: BAYER. Form: TABLET. Route: ORAL

    full page →NAPROXEN SODIUM →fda approvals ↗
    ›Nov 13, 2012approval

    Week of Nov 19, 2012

    6
    ›Nov 19, 2012approval5006d agoPROTRIPTYLINE HYDROCHLORIDE — FDA approvalPROTRIPTYLINE HYDROCHLORIDE

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

    full page →PROTRIPTYLINE HYDROCHLORIDE →fda approvals ↗
    ›Nov 19, 2012approval

    Week of Nov 26, 2012

    2
    ›Nov 27, 2012approval4998d agoDUREZOL (DIFLUPREDNATE) — FDA approvalDIFLUPREDNATE

    Sponsor: SANDOZ. Form: EMULSION. Route: OPHTHALMIC

    full page →DIFLUPREDNATE →fda approvals ↗
    ›Nov 29, 2012approval
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    page 125 of 380
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    5054d ago
    IMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

    Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
    ›Oct 2, 2012approval5054d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

    Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
    ›Oct 2, 2012approval5054d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

    Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
    ›Oct 2, 2012approval5054d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

    Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
    ›Oct 3, 2012approval5053d agoIRBESARTAN — FDA approvalIRBESARTAN

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

    full page →IRBESARTAN →fda approvals ↗
    ›Oct 4, 2012approval5052d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

    Sponsor: ACTELION. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 5, 2012approval5051d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

    full page →certolizumab pegol →fda approvals ↗
    ›Oct 5, 2012approval5051d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

    full page →certolizumab pegol →fda approvals ↗
    5045d ago
    COMBIGAN (BRIMONIDINE TARTRATE) — FDA approvalLumify

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

    full page →Lumify →fda approvals ↗
    ›Oct 11, 2012approval5045d agoPEPCID AC (FAMOTIDINE) — FDA approvalKenvue Inc.

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

    full page →fda approvals ↗
    ›Oct 11, 2012approval5045d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

    full page →tocilizumab →fda approvals ↗
    ›Oct 12, 2012approval5044d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: IMPAX LABS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 12, 2012approval5044d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: IMPAX LABS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    5041d ago
    NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

    Sponsor: COLLEGIUM PHARM INC. Form: SOLUTION. Route: ORAL

    full page →tapentadol hydrochloride ER →fda approvals ↗
    ›Oct 15, 2012approval5041d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    5027d ago
    TOPAMAX (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Oct 29, 2012approval5027d agoOMEPRAZOLE — FDA approvalomeprazole DR

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

    full page →omeprazole DR →fda approvals ↗
    ›Oct 30, 2012approval5026d agoVALACYCLOVIR HYDROCHLORIDE — FDA approvalVALACYCLOVIR HYDROCHLORIDE

    Sponsor: JUBILANT GENERICS. Form: TABLET. Route: ORAL

    full page →VALACYCLOVIR HYDROCHLORIDE →fda approvals ↗
    ›Nov 1, 2012approval5024d agoQSYMIA (PHENTERMINE HYDROCHLORIDE) — FDA approval(phentermine hydrochloride + topiramate) ER

    Sponsor: VIVUS LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →(phentermine hydrochloride + topiramate) ER →fda approvals ↗
    ›Nov 2, 2012approval5023d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Nov 2, 2012approval5023d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Nov 2, 2012approval5023d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Nov 2, 2012approval5023d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

    Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Nov 2, 2012approval5023d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    5019d ago
    XELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

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

    full page →fda approvals ↗
    ›Nov 6, 2012approval5019d agoSUPREP BOWEL PREP KIT (MAGNESIUM SULFATE) — FDA approvalMAGNESIUM SULFATE

    Sponsor: AZURITY. Form: SOLUTION. Route: ORAL

    full page →MAGNESIUM SULFATE →fda approvals ↗
    ›Nov 8, 2012approval5017d agoBENAZEPRIL HYDROCHLORIDE — FDA approvalBENAZEPRIL HYDROCHLORIDE

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

    full page →BENAZEPRIL HYDROCHLORIDE →fda approvals ↗
    ›Nov 8, 2012approval5017d agoBENAZEPRIL HYDROCHLORIDE — FDA approvalBENAZEPRIL HYDROCHLORIDE

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

    full page →BENAZEPRIL HYDROCHLORIDE →fda approvals ↗
    ›Nov 9, 2012approval5016d agoDYNA-HEX 4 (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

    Sponsor: XTTRIUM. Form: SOLUTION. Route: TOPICAL

    full page →fda approvals ↗
    5012d ago
    TRIAMCINOLONE ACETONIDE — FDA approvaltriamcinolone acetonide Rising

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

    full page →triamcinolone acetonide Rising →fda approvals ↗
    ›Nov 15, 2012approval5010d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

    full page →certolizumab pegol →fda approvals ↗
    ›Nov 16, 2012approval5009d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalFLUOXETINE HYDROCHLORIDE

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

    full page →FLUOXETINE HYDROCHLORIDE →fda approvals ↗
    ›Nov 16, 2012approval5009d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

    Sponsor: IPCA LABS LTD. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    5006d ago
    VYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 19, 2012approval5006d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 19, 2012approval5006d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 21, 2012approval5004d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Nov 23, 2012approval5002d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

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

    full page →fda approvals ↗
    4996d ago
    COMETRIQ (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

    Sponsor: EXELIXIS. Form: CAPSULE. Route: ORAL

    full page →cabozantinib s-malate →fda approvals ↗
    $ABBV245.10-2.33%
    $AMRX18.85+2.89%
    $KVUE19.01-1.20%
    $ABBV245.10-2.33%
    $COLL35.58+0.54%
    $AMRX18.85+2.89%
    $EXEL55.06+3.83%