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calendar

28,212 catalysts · 17,794 approval · 4,104 device 510k · 2,472 grant · 1,580 device recall · 1,358 device pma · 904 recall

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approval17,794
device 510k4,104
grant2,472
device recall1,580
device pma1,358
recall904

therapy area

no tagged catalysts yet

Week of Sep 24, 2012

›Sep 27, 2012approval5085d agoIRBESARTAN — FDA approvalIRBESARTAN

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

full page →IRBESARTAN →fda approvals ↗

›Sep 27, 2012approval5085d agoIRBESARTAN — FDA approvalIRBESARTAN

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

full page →IRBESARTAN →fda approvals ↗

›Sep 28, 2012approval5084d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

Sponsor: ABBVIE INC. Form: VIAL

full page →adalimumab →fda approvals ↗

Week of Oct 1, 2012

›Oct 2, 2012approval5080d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Oct 2, 2012approval5080d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗

›Oct 2, 2012approval5080d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗

›Oct 2, 2012approval5080d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗

›Oct 2, 2012approval5080d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗

›Oct 3, 2012approval5079d agoIRBESARTAN — FDA approvalIRBESARTAN

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

full page →IRBESARTAN →fda approvals ↗

›Oct 4, 2012approval5078d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Oct 5, 2012approval5077d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

full page →certolizumab pegol →fda approvals ↗

›Oct 5, 2012approval5077d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

full page →certolizumab pegol →fda approvals ↗

Week of Oct 8, 2012

›Oct 9, 2012approval5073d agoCAPRELSA (VANDETANIB) — FDA approvalvandetanib

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

full page →vandetanib →fda approvals ↗

›Oct 11, 2012approval5071d agoCOMBIGAN (BRIMONIDINE TARTRATE) — FDA approvalLumify

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

full page →Lumify →fda approvals ↗

›Oct 11, 2012approval5071d agoPEPCID AC (FAMOTIDINE) — FDA approvalKenvue Inc.

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

full page →fda approvals ↗

›Oct 11, 2012approval5071d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

full page →tocilizumab →fda approvals ↗

›Oct 12, 2012approval5070d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›Oct 12, 2012approval5070d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Week of Oct 15, 2012

›Oct 15, 2012approval5067d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

›Oct 15, 2012approval5067d agoNUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

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

full page →tapentadol hydrochloride ER →fda approvals ↗

›Oct 15, 2012approval5067d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Week of Oct 29, 2012

›Oct 29, 2012approval5053d agoTOPAMAX SPRINKLE (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

›Oct 29, 2012approval5053d agoTOPAMAX (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

›Oct 29, 2012approval5053d agoOMEPRAZOLE — FDA approvalomeprazole DR

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

full page →omeprazole DR →fda approvals ↗

›Oct 30, 2012approval5052d agoVALACYCLOVIR HYDROCHLORIDE — FDA approvalVALACYCLOVIR HYDROCHLORIDE

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

full page →VALACYCLOVIR HYDROCHLORIDE →fda approvals ↗

›Nov 1, 2012approval5050d 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, 2012approval5049d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

›Nov 2, 2012approval5049d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

›Nov 2, 2012approval5049d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

›Nov 2, 2012approval5049d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

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

full page →fda approvals ↗

›Nov 2, 2012approval5049d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Week of Nov 5, 2012

›Nov 5, 2012approval5046d agoSALONPAS (MENTHOL) — FDA approvalHisamitsu America Inc

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

full page →fda approvals ↗

›Nov 6, 2012approval5045d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

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

full page →fda approvals ↗

›Nov 6, 2012approval5045d agoSUPREP BOWEL PREP KIT (MAGNESIUM SULFATE) — FDA approvalMAGNESIUM SULFATE

Sponsor: AZURITY. Form: SOLUTION. Route: ORAL

full page →MAGNESIUM SULFATE →fda approvals ↗

›Nov 8, 2012approval5043d agoBENAZEPRIL HYDROCHLORIDE — FDA approvalBENAZEPRIL HYDROCHLORIDE

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

full page →BENAZEPRIL HYDROCHLORIDE →fda approvals ↗

›Nov 8, 2012approval5043d agoBENAZEPRIL HYDROCHLORIDE — FDA approvalBENAZEPRIL HYDROCHLORIDE

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

full page →BENAZEPRIL HYDROCHLORIDE →fda approvals ↗

›Nov 9, 2012approval5042d agoDYNA-HEX 4 (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

Sponsor: XTTRIUM. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗

Week of Nov 12, 2012

›Nov 13, 2012approval5038d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

Sponsor: BAYER. Form: TABLET. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗

›Nov 13, 2012approval5038d agoTRIAMCINOLONE ACETONIDE — FDA approvaltriamcinolone acetonide Rising

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →triamcinolone acetonide Rising →fda approvals ↗

›Nov 15, 2012approval5036d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

full page →certolizumab pegol →fda approvals ↗

›Nov 16, 2012approval5035d 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, 2012approval5035d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

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

full page →fda approvals ↗

Week of Nov 19, 2012

›Nov 19, 2012approval5032d agoPROTRIPTYLINE HYDROCHLORIDE — FDA approvalPROTRIPTYLINE HYDROCHLORIDE

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

full page →PROTRIPTYLINE HYDROCHLORIDE →fda approvals ↗

›Nov 19, 2012approval5032d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Nov 19, 2012approval5032d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Nov 19, 2012approval5032d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Nov 21, 2012approval5030d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

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

full page →fda approvals ↗

›Nov 23, 2012approval5028d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

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

full page →fda approvals ↗

Week of Nov 26, 2012

›Nov 27, 2012approval5024d agoDUREZOL (DIFLUPREDNATE) — FDA approvalDIFLUPREDNATE

Sponsor: SANDOZ. Form: EMULSION. Route: OPHTHALMIC

full page →DIFLUPREDNATE →fda approvals ↗

›Nov 29, 2012approval5022d agoCOMETRIQ (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

Sponsor: EXELIXIS. Form: CAPSULE. Route: ORAL

full page →cabozantinib s-malate →fda approvals ↗

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$COLL25.35-4.12%

$ABBV255.48-1.03%

$AMRX17.54-2.61%

$ABBV255.48-1.03%

$KVUE19.17-0.16%

$AMRX17.54-2.61%

$EXEL54.45-1.47%