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calendar

29,078 catalysts · 9,616 approval · 5,000 device 510k · 4,728 grant · 2,603 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2017-08-12×clear all

type

approval9,616
device 510k5,000
grant4,728
8k filing2,603
device pma2,000
device recall2,000
recall1,126

device adverse event1,000

pdufa347

earnings311

therapy area

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

Week of Aug 7, 2017

›Aug 12, 2017approval3278d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL

full page →tedizolid phosphate →fda approvals ↗

›Aug 12, 2017approval3278d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL

full page →tedizolid phosphate →fda approvals ↗

›Aug 12, 2017approval3278d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS

full page →tedizolid phosphate →fda approvals ↗

›Aug 12, 2017approval3278d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS

full page →tedizolid phosphate →fda approvals ↗

Week of Aug 14, 2017

›Aug 14, 2017approval3276d agoBUTRANS (BUPRENORPHINE) — FDA approvalBUTRANS

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

full page →BUTRANS →fda approvals ↗

›Aug 14, 2017approval

Week of Aug 21, 2017

›Aug 21, 2017approval3269d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: SUN PHARM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Aug 21, 2017approval

Week of Aug 28, 2017

›Aug 28, 2017approval3262d agoMARINOL (DRONABINOL) — FDA approvalVertanical GmbH

Sponsor: ALKEM LABS LTD. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Aug 29, 2017approval

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3276d ago

METFORMIN HYDROCHLORIDE — FDA approvalCenter for Biomedical Research for Neurodegenetive Diseases

Sponsor: GRANULES INDIA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Aug 14, 2017approval3276d agoMETFORMIN HYDROCHLORIDE — FDA approvalCenter for Biomedical Research for Neurodegenetive Diseases

Sponsor: GRANULES INDIA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Aug 15, 2017approval3275d agoOPILL (NORGESTREL) — FDA approvalHRA Pharma LLC

Sponsor: LABORATOIRE HRA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Aug 15, 2017approval3275d agoOPILL (NORGESTREL) — FDA approvalHRA Pharma LLC

Sponsor: LABORATOIRE HRA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Aug 16, 2017approval3274d agoDEMEROL (MEPERIDINE HYDROCHLORIDE) — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: QUAGEN. Form: TABLET. Route: ORAL

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

3269d ago

TRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: SUN PHARM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Aug 21, 2017approval3269d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

full page →tramadol hydrochloride ER →fda approvals ↗

›Aug 21, 2017approval3269d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

full page →tramadol hydrochloride ER →fda approvals ↗

›Aug 21, 2017approval3269d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: STRIDES PHARMA INTL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

›Aug 21, 2017approval3269d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: STRIDES PHARMA INTL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

›Aug 22, 2017approval3268d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

Sponsor: BAYER. Form: TABLET. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗

›Aug 22, 2017approval3268d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

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

full page →tofacitinib citrate ER →fda approvals ↗

›Aug 22, 2017approval3268d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

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

full page →tofacitinib citrate ER →fda approvals ↗

›Aug 22, 2017approval3268d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

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

full page →fda approvals ↗

›Aug 22, 2017approval3268d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

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

full page →fda approvals ↗

›Aug 23, 2017approval3267d agoFLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

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

full page →fda approvals ↗

›Aug 24, 2017approval3266d agoAZITHROMYCIN — FDA approvalPFIZER INC

Sponsor: CHARTWELL RX. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

›Aug 24, 2017approval3266d agoAZITHROMYCIN — FDA approvalPFIZER INC

Sponsor: CHARTWELL RX. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

›Aug 25, 2017approval3265d agoDEXMEDETOMIDINE HYDROCHLORIDE — FDA approvalDEXMEDETOMIDINE HYDROCHLORIDE

Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

full page →DEXMEDETOMIDINE HYDROCHLORIDE →fda approvals ↗

›Aug 25, 2017approval3265d agoDEXMEDETOMIDINE HYDROCHLORIDE — FDA approvalDEXMEDETOMIDINE HYDROCHLORIDE

Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

full page →DEXMEDETOMIDINE HYDROCHLORIDE →fda approvals ↗

›Aug 25, 2017approval3265d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Aug 25, 2017approval3265d agoBUPROPION HYDROCHLORIDE — FDA approvalIpca Pharmaceuticals Inc

Sponsor: PH HEALTH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Aug 25, 2017approval3265d agoBUPROPION HYDROCHLORIDE — FDA approvalIpca Pharmaceuticals Inc

Sponsor: PH HEALTH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Aug 25, 2017approval3265d agoCYLTEZO (ADALIMUMAB-ADBM) — FDA approvalCYLTEZO

Sponsor: BOEHRINGER INGELHEIM. Form: INJECTABLE. Route: INJECTION

full page →CYLTEZO →fda approvals ↗

›Aug 25, 2017approval3265d agoVICTOZA (LIRAGLUTIDE) — FDA approvalSaxenda

Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →Saxenda →fda approvals ↗

3261d ago

SOLIQUA 100/33 (INSULIN GLARGINE) — FDA approvalToujeo LA

Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS

full page →Toujeo LA →fda approvals ↗

›Aug 29, 2017approval3261d agoVABOMERE (MEROPENEM) — FDA approvalHQ Speciality Pharma

Sponsor: REMPEX. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

›Aug 29, 2017approval3261d agoREGLAN (METOCLOPRAMIDE HYDROCHLORIDE) — FDA approvalANI PHARMACEUTICALS INC

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

full page →fda approvals ↗

›Aug 29, 2017approval3261d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: SUN PHARM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Aug 29, 2017approval3261d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: SUN PHARM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Aug 29, 2017approval3261d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Sponsor: COSETTE. Form: SYRUP. Route: ORAL

full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗

›Aug 29, 2017approval3261d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: PH HEALTH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Aug 29, 2017approval3261d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: SUN PHARM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Aug 29, 2017approval3261d agoPROMETHAZINE WITH CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

Sponsor: PHARM ASSOC. Form: SYRUP. Route: ORAL

full page →fda approvals ↗

›Aug 29, 2017approval3261d agoPROMETHAZINE WITH CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

Sponsor: PHARM ASSOC. Form: SYRUP. Route: ORAL

full page →fda approvals ↗

›Aug 29, 2017approval3261d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

full page →tramadol hydrochloride ER →fda approvals ↗

›Aug 29, 2017approval3261d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

full page →tramadol hydrochloride ER →fda approvals ↗

›Aug 29, 2017approval3261d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

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

full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗

›Aug 29, 2017approval3261d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: LUPIN LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

›Aug 29, 2017approval3261d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Aug 29, 2017approval3261d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Aug 29, 2017approval3261d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →fda approvals ↗

›Aug 29, 2017approval3261d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

Sponsor: CHARTWELL RX. Form: SYRUP. Route: ORAL

full page →fda approvals ↗

$NVO47.08-8.78%

$PFE25.01+0.40%

$ANIP79.24-1.48%

$PFE25.01+0.40%