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18,993 catalysts · 18,987 approval · 5,539 phase readout · 5,000 device 510k · 4,728 grant · 2,701 8k filing · 2,000 device pma

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  • approval18,987
  • phase readout5,539
  • device 510k5,000
  • grant4,728
  • 8k filing2,701
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • pdufa383
  • therapy area
    • Ophthalmology5

    Week of Mar 4, 2013

    8
    ›Mar 5, 2013approval4901d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    ›Mar 6, 2013approval4900d agoTEGRETOL-XR (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

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

    full page →carbamazepine ER →fda approvals ↗
    ›Mar 6, 2013approval4900d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Mar 6, 2013approval4900d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

    Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Mar 7, 2013approval4899d agoFENTANYL-75 (FENTANYL) — FDA approvalDifGen Pharmaceuticals LLC

    Sponsor: DIFGEN PHARMS. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

    full page →fda approvals ↗
    ›Mar 8, 2013approval4898d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

    Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL

    full page →IBANDRONATE SODIUM →fda approvals ↗
    ›Mar 8, 2013approval4898d agoBUTRANS (BUPRENORPHINE) — FDA approvalBUTRANS

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

    full page →BUTRANS →fda approvals ↗
    ›Mar 8, 2013approval4898d agoADDERALL XR 10 (AMPHETAMINE ASPARTATE) — FDA approvalTakeda Pharmaceuticals USA Inc

    Sponsor: TAKEDA PHARMS USA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗

    Week of Mar 11, 2013

    7
    ›Mar 11, 2013approval4895d agoIRBESARTAN — FDA approvalIRBESARTAN

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

    full page →IRBESARTAN →fda approvals ↗
    ›Mar 12, 2013approval

    Week of Mar 18, 2013

    7
    ›Mar 18, 2013approval4888d agoOLANZAPINE — FDA approvalolanzapine ODT

    Sponsor: DR REDDYS LABS LTD. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →olanzapine ODT →fda approvals ↗
    ›Mar 19, 2013approval

    Week of Mar 25, 2013

    13
    ›Mar 25, 2013approval4881d agoZENATANE (ISOTRETINOIN) — FDA approvalISOTRETINOIN

    Sponsor: DR REDDYS LABS LTD. Form: CAPSULE. Route: ORAL

    full page →ISOTRETINOIN →fda approvals ↗
    ›Mar 25, 2013approval

    Week of Apr 1, 2013

    6
    ›Apr 1, 2013approval4874d agoPEPCID AC (FAMOTIDINE) — FDA approvalKenvue Inc.

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

    full page →fda approvals ↗
    ›Apr 1, 2013approval

    Week of Apr 8, 2013

    7
    ›Apr 9, 2013approval4866d agoCONZIP (TRAMADOL HYDROCHLORIDE) — FDA approvalTrigen Laboratories Inc

    Sponsor: CIPHER PHARMS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

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

    Week of Apr 15, 2013

    2
    ›Apr 15, 2013approval4860d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    ›Apr 15, 2013approval
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    page 128 of 380
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    4894d ago
    TRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

    Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

    full page →triptorelin pamoate ER →fda approvals ↗
    ›Mar 12, 2013approval4894d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

    Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

    full page →triptorelin pamoate ER →fda approvals ↗
    ›Mar 12, 2013approval4894d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

    Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

    full page →triptorelin pamoate ER →fda approvals ↗
    ›Mar 14, 2013approval4892d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

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

    full page →fda approvals ↗
    ›Mar 14, 2013approval4892d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalAlembic Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Mar 14, 2013approval4892d agoTECHNESCAN HDP (TECHNETIUM TC-99M OXIDRONATE KIT) — FDA approval

    Sponsor: CURIUM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    4887d ago
    QSYMIA (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 ↗
    ›Mar 19, 2013approval4887d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →LOSARTAN POTASSIUM →fda approvals ↗
    ›Mar 19, 2013approval4887d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

    Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

    full page →enzalutamide →fda approvals ↗
    ›Mar 19, 2013approval4887d agoWELLBUTRIN SR (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Mar 19, 2013approval4887d agoWELLBUTRIN (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Mar 22, 2013approval4884d agoDUREZOL (DIFLUPREDNATE) — FDA approvalDIFLUPREDNATE

    Sponsor: SANDOZ. Form: EMULSION. Route: OPHTHALMIC

    full page →DIFLUPREDNATE →fda approvals ↗
    4881d ago
    OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

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

    full page →fda approvals ↗
    ›Mar 25, 2013approval4881d agoDEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →medroxyprogesterone acetate →fda approvals ↗
    ›Mar 26, 2013approval4880d agoMIFEPREX (MIFEPRISTONE) — FDA approvalCORCEPT THERAPEUTICS INC

    Sponsor: DANCO LABS LLC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Mar 27, 2013approval4879d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

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

    full page →fda approvals ↗
    ›Mar 27, 2013approval4879d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: TRIS PHARMA INC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Mar 27, 2013approval4879d agoVORICONAZOLE — FDA approvalMylan Pharmaceuticals Inc

    Sponsor: MYLAN PHARMS INC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Mar 28, 2013approval4878d agoKARBINAL ER (CARBINOXAMINE MALEATE) — FDA approvalAYTU BIOPHARMA, INC

    Sponsor: AYTU. Form: SUSPENSION, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Mar 28, 2013approval4878d agoKETOROLAC TROMETHAMINE — FDA approvalKetorolac Tromethamine Apotex

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

    full page →Ketorolac Tromethamine Apotex →fda approvals ↗
    ›Mar 28, 2013approval4878d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

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

    full page →naltrexone ER →fda approvals ↗
    ›Mar 29, 2013approval4877d agoVENOFER (IRON SUCROSE) — FDA approvalInternational Medication Systems Ltd

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

    full page →fda approvals ↗
    ›Mar 29, 2013approval4877d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

    Sponsor: CSPC OUYI PHARM CO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Mar 29, 2013approval4877d agoSALONPAS (MENTHOL) — FDA approvalHisamitsu America Inc

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

    full page →fda approvals ↗
    4874d ago
    NAPROXEN SODIUM — FDA approvalNAPROXEN SODIUM

    Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL

    full page →NAPROXEN SODIUM →fda approvals ↗
    ›Apr 1, 2013approval4874d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

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

    full page →fda approvals ↗
    ›Apr 2, 2013approval4873d agoSUPPRELIN LA (HISTRELIN ACETATE) — FDA approvalEndo Pharmaceuticals Inc

    Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Apr 4, 2013approval4871d agoVANTAS (HISTRELIN ACETATE) — FDA approvalEndo Pharmaceuticals Inc

    Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Apr 5, 2013approval4870d agoSTALEVO 75 (CARBIDOPA) — FDA approvalcarbidopa

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

    full page →carbidopa →fda approvals ↗
    4865d ago
    JUXTAPID (LOMITAPIDE MESYLATE) — FDA approvalChiesi USA Inc

    Sponsor: CHIESI. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Apr 10, 2013approval4865d agoDAYSEE (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

    Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL

    full page →NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE →fda approvals ↗
    ›Apr 11, 2013approval4864d agoXeomin (incobotulinumtoxinA) — FDA approvalMerz Pharmaceuticals LLC

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

    full page →fda approvals ↗
    ›Apr 11, 2013approval4864d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

    Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

    full page →triptorelin pamoate ER →fda approvals ↗
    ›Apr 11, 2013approval4864d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

    Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

    full page →triptorelin pamoate ER →fda approvals ↗
    ›Apr 12, 2013approval4863d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    4860d ago
    OXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

    Sponsor: ACTAVIS ELIZABETH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
    $NVS153.16-0.33%
    $NVS153.16-0.33%
    $RDY12.13+0.46%
    $RDY12.13+0.46%
    $NVS153.16-0.33%
    $RDY12.13+0.46%
    $KVUE19.14+0.68%
    $PFE25.32+1.18%
    $CORT111.89-0.81%
    $TRAW
    $AYTU2.2300-0.89%
    $ORN12.42-2.13%
    $ALKS49.53+1.10%
    $KVUE19.14+0.68%