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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 Nov 2, 2015

10
›Nov 4, 2015approval3953d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗
›Nov 5, 2015approval3952d agoIOPIDINE (APRACLONIDINE HYDROCHLORIDE) — FDA approvalHARROW, INC.

Sponsor: HARROW EYE. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗
›Nov 5, 2015approval3952d agoOLANZAPINE — FDA approvalolanzapine ODT

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

full page →olanzapine ODT →fda approvals ↗
›Nov 5, 2015approval3952d agoOLANZAPINE — FDA approvalolanzapine ODT

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

full page →olanzapine ODT →fda approvals ↗
›Nov 5, 2015approval3952d agoOLANZAPINE — FDA approvalolanzapine ODT

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

full page →olanzapine ODT →fda approvals ↗
›Nov 5, 2015approval3952d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

full page →fda approvals ↗
›Nov 5, 2015approval3952d agoANASTROZOLE — FDA approvalANASTROZOLE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →ANASTROZOLE →fda approvals ↗
›Nov 5, 2015approval3952d agoANASTROZOLE — FDA approvalANASTROZOLE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →ANASTROZOLE →fda approvals ↗
›Nov 6, 2015approval3951d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

full page →enzalutamide →fda approvals ↗
›Nov 6, 2015approval3951d agoIRBESARTAN — FDA approvalIRBESARTAN

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

full page →IRBESARTAN →fda approvals ↗

Week of Nov 9, 2015

20
›Nov 9, 2015approval3948d agoCEFEPIME AND DEXTROSE IN DUPLEX CONTAINER (CEFEPIME HYDROCHLORIDE) — FDA approvalSamson Medical Technologies LLC

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

full page →fda approvals ↗
›Nov 9, 2015approval3948d agoFOLLISTIM AQ (FOLLITROPIN ALFA/BETA) — FDA approvalfollitropin beta

Sponsor: ORGANON USA LLC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →follitropin beta →fda approvals ↗
›Nov 9, 2015approval3948d agoTEMOZOLOMIDE — FDA approvalAreva Pharmaceuticals Inc

Sponsor: SUN PHARM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Nov 9, 2015approval3948d agoTRAMADOL HYDROCHLORIDE — FDA approvalSenores Pharmaceuticals Inc

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

full page →fda approvals ↗
›Nov 9, 2015approval3948d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Nov 9, 2015approval3948d agoFENTANYL CITRATE — FDA approvalEffentora

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →Effentora →fda approvals ↗
›Nov 9, 2015approval3948d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

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

full page →fda approvals ↗
›Nov 10, 2015approval3947d agoQOLIANA (BRIMONIDINE TARTRATE) — FDA approvalLumify

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

full page →Lumify →fda approvals ↗
›Nov 10, 2015approval3947d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
›Nov 10, 2015approval3947d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
›Nov 12, 2015approval3945d agoDEXMETHYLPHENIDATE HYDROCHLORIDE — FDA approvaldexmethylphenidate hydrochloride ER

Sponsor: AUROLIFE PHARMA LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗
›Nov 12, 2015approval3945d agoBENAZEPRIL HYDROCHLORIDE — FDA approvalBENAZEPRIL HYDROCHLORIDE

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

full page →BENAZEPRIL HYDROCHLORIDE →fda approvals ↗
›Nov 12, 2015approval3945d agoOXYCONTIN (OXYCODONE HYDROCHLORIDE) — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: PURDUE PHARMA LP. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Nov 13, 2015approval3944d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →POSACONAZOLE →fda approvals ↗
›Nov 13, 2015approval3944d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →POSACONAZOLE →fda approvals ↗
›Nov 13, 2015approval3944d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Nov 13, 2015approval3944d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Nov 13, 2015approval3944d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MERCK SHARP DOHME. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →POSACONAZOLE →fda approvals ↗
›Nov 13, 2015approval3944d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MERCK SHARP DOHME. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →POSACONAZOLE →fda approvals ↗
›Nov 13, 2015approval3944d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Week of Nov 16, 2015

10
›Nov 16, 2015approval3941d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Nov 17, 2015approval3940d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: SANDOZ. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗
›Nov 18, 2015approval3939d agoNARCAN (NALOXONE HYDROCHLORIDE) — FDA approvalEmergent Devices Inc

Sponsor: EMERGENT. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗
›Nov 19, 2015approval3938d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
›Nov 20, 2015approval3937d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗
›Nov 20, 2015approval3937d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗
›Nov 20, 2015approval3937d agoXeomin (incobotulinumtoxinA) — FDA approvalMerz Pharmaceuticals LLC

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

full page →fda approvals ↗
›Nov 20, 2015approval3937d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

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

full page →fda approvals ↗
›Nov 20, 2015approval3937d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

Sponsor: LGM PHARMA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Nov 20, 2015approval3937d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

full page →taliglucerase alfa →fda approvals ↗

Week of Nov 23, 2015

8
›Nov 23, 2015approval3934d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗
›Nov 23, 2015approval3934d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗
›Nov 23, 2015approval3934d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

Sponsor: ABBVIE INC. Form: VIAL

full page →adalimumab →fda approvals ↗
›Nov 23, 2015approval3934d agoLINZESS (LINACLOTIDE) — FDA approvallinaclotide

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →linaclotide →fda approvals ↗
›Nov 24, 2015approval3933d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

full page →fda approvals ↗
›Nov 25, 2015approval3932d agoGADAVIST (GADOBUTROL) — FDA approval

Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗
›Nov 25, 2015approval3932d agoFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) — FDA approvalParatek Pharmaceuticals Inc

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

full page →fda approvals ↗
›Nov 25, 2015approval3932d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

Sponsor: PHARMACYCLICS LLC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Week of Nov 30, 2015

2
›Nov 30, 2015approval3927d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗
›Nov 30, 2015approval3927d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗
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$BMY66.58-0.55%
$BMY66.58-0.55%
$PFE27.96-0.21%
$CPIX8.4600-2.20%
$NVS153.81-0.54%
$ABBV255.48-1.03%
$VERX14.22-0.52%
$HROW37.27-3.30%
$ABBV255.48-1.03%
$NVS153.81-0.54%
$ABBV255.48-1.03%