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calendar

30,848 catalysts · 11,243 approval · 5,000 device 510k · 4,728 grant · 3,086 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2015-06-16×clear all

type

approval11,243
device 510k5,000
grant4,728
8k filing3,086
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings583

phase 2 completion172

therapy area

Oncology148
Infectious Disease46
Cardiology37
Immunology35
Dermatology31
Pulmonology22
Women's Health19
Ophthalmology16
Pain15

Week of Oct 26, 2015

›Oct 30, 2015approval3939d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

›Oct 31, 2015approval3938d agoMOMETASONE FUROATE — FDA approvalFougera Pharmaceuticals Inc

Sponsor: FOUGERA PHARMS. Form: OINTMENT. Route: TOPICAL

full page →fda approvals ↗

Week of Nov 2, 2015

›Nov 2, 2015approval3936d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

Sponsor: NOVARTIS. Form: INJECTABLE. Route: INJECTION

full page →Restasis →fda approvals ↗

›Nov 2, 2015approval

Week of Nov 9, 2015

›Nov 9, 2015approval3929d 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, 2015approval

Week of Nov 16, 2015

›Nov 16, 2015approval3922d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

›Nov 17, 2015approval

Week of Nov 23, 2015

›Nov 23, 2015approval3915d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

›Nov 23, 2015approval

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page 6 of 617

3936d ago

HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Nov 3, 2015approval3935d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

Sponsor: LUNDBECK PHARMS LLC. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Nov 3, 2015approval3935d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Nov 3, 2015approval3935d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Nov 3, 2015approval3935d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Nov 4, 2015approval3934d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

›Nov 5, 2015approval3933d agoIOPIDINE (APRACLONIDINE HYDROCHLORIDE) — FDA approvalHARROW, INC.

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

full page →fda approvals ↗

›Nov 5, 2015approval3933d agoOLANZAPINE — FDA approvalolanzapine ODT

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

full page →olanzapine ODT →fda approvals ↗

›Nov 5, 2015approval3933d agoOLANZAPINE — FDA approvalolanzapine ODT

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

full page →olanzapine ODT →fda approvals ↗

›Nov 5, 2015approval3933d agoOLANZAPINE — FDA approvalolanzapine ODT

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

full page →olanzapine ODT →fda approvals ↗

›Nov 5, 2015approval3933d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

full page →fda approvals ↗

›Nov 5, 2015approval3933d agoANASTROZOLE — FDA approvalANASTROZOLE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →ANASTROZOLE →fda approvals ↗

›Nov 5, 2015approval3933d agoANASTROZOLE — FDA approvalANASTROZOLE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →ANASTROZOLE →fda approvals ↗

›Nov 6, 2015approval3932d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

full page →enzalutamide →fda approvals ↗

›Nov 6, 2015approval3932d agoIRBESARTAN — FDA approvalIRBESARTAN

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

full page →IRBESARTAN →fda approvals ↗

3929d ago

FOLLISTIM AQ (FOLLITROPIN ALFA/BETA) — FDA approvalfollitropin beta

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

full page →follitropin beta →fda approvals ↗

›Nov 9, 2015approval3929d agoTEMOZOLOMIDE — FDA approvalAreva Pharmaceuticals Inc

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

full page →fda approvals ↗

›Nov 9, 2015approval3929d agoTRAMADOL HYDROCHLORIDE — FDA approvalSenores Pharmaceuticals Inc

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

full page →fda approvals ↗

›Nov 9, 2015approval3929d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 9, 2015approval3929d agoFENTANYL CITRATE — FDA approvalEffentora

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →Effentora →fda approvals ↗

›Nov 9, 2015approval3929d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

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

full page →fda approvals ↗

›Nov 10, 2015approval3928d agoQOLIANA (BRIMONIDINE TARTRATE) — FDA approvalLumify

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

full page →Lumify →fda approvals ↗

›Nov 10, 2015approval3928d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Nov 10, 2015approval3928d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Nov 12, 2015approval3926d 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, 2015approval3926d agoBENAZEPRIL HYDROCHLORIDE — FDA approvalBENAZEPRIL HYDROCHLORIDE

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

full page →BENAZEPRIL HYDROCHLORIDE →fda approvals ↗

›Nov 12, 2015approval3926d agoOXYCONTIN (OXYCODONE HYDROCHLORIDE) — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

›Nov 13, 2015approval3925d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

full page →POSACONAZOLE →fda approvals ↗

›Nov 13, 2015approval3925d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

full page →POSACONAZOLE →fda approvals ↗

›Nov 13, 2015approval3925d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗

›Nov 13, 2015approval3925d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗

›Nov 13, 2015approval3925d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

full page →POSACONAZOLE →fda approvals ↗

›Nov 13, 2015approval3925d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

full page →POSACONAZOLE →fda approvals ↗

›Nov 13, 2015approval3925d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

3921d ago

LEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: SANDOZ. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

›Nov 18, 2015approval3920d agoNARCAN (NALOXONE HYDROCHLORIDE) — FDA approvalEmergent Devices Inc

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

full page →fda approvals ↗

›Nov 19, 2015approval3919d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗

›Nov 20, 2015approval3918d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

›Nov 20, 2015approval3918d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

›Nov 20, 2015approval3918d agoXeomin (incobotulinumtoxinA) — FDA approvalMerz Pharmaceuticals LLC

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

full page →fda approvals ↗

›Nov 20, 2015approval3918d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

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

full page →fda approvals ↗

›Nov 20, 2015approval3918d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

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

full page →fda approvals ↗

›Nov 20, 2015approval3918d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

full page →taliglucerase alfa →fda approvals ↗

3915d ago

OPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

$NVS155.21-1.01%

$BMY64.84+0.19%

$HROW38.42-5.60%

$NVS155.21-1.01%

$PFE26.63-1.57%

$CPIX7.7900-0.13%

$BMY64.84+0.19%