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calendar

28,804 catalysts · 9,524 approval · 5,000 device 510k · 4,728 grant · 2,761 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2017-08-31×clear all

type

approval9,524
device 510k5,000
grant4,728
8k filing2,761
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings356

phase 2 completion172

therapy area

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

Week of Dec 31, 2018

›Jan 4, 2019approval2771d agoESTRADIOL — FDA approvalestradiol ER

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

full page →estradiol ER →fda approvals ↗

›Jan 4, 2019approval2771d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗

›Jan 4, 2019approval2771d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗

Week of Jan 7, 2019

›Jan 10, 2019approval2765d agoFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) — FDA approvaldexmethylphenidate hydrochloride ER

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

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗

›Jan 10, 2019

Week of Jan 14, 2019

›Jan 14, 2019approval2761d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jan 14, 2019approval

Week of Jan 21, 2019

›Jan 23, 2019approval2752d agoBRAFTOVI (ENCORAFENIB) — FDA approvalencorafenib

Sponsor: ARRAY BIOPHARMA INC. Form: CAPSULE. Route: ORAL

full page →encorafenib →fda approvals ↗

›Jan 23, 2019approval

Week of Jan 28, 2019

›Jan 28, 2019approval2747d agoOMEPRAZOLE — FDA approvalomeprazole DR

Sponsor: DEXCEL. Form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE. Route: ORAL

full page →omeprazole DR →fda approvals ↗

›Jan 28, 2019approval

Week of Feb 4, 2019

›Feb 4, 2019approval2740d agoLABETALOL HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Feb 4, 2019approval

← prev

page 21 of 577

approval

2765d ago

FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) — FDA approvaldexmethylphenidate hydrochloride ER

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

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗

›Jan 10, 2019approval2765d agoRITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalRITALIN LA

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

full page →RITALIN LA →fda approvals ↗

›Jan 10, 2019approval2765d agoRITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalRITALIN LA

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

full page →RITALIN LA →fda approvals ↗

›Jan 11, 2019approval2764d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

Sponsor: ABBVIE INC. Form: VIAL

full page →adalimumab →fda approvals ↗

›Jan 11, 2019approval2764d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: RISING. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

2761d ago

CABOMETYX (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

Sponsor: EXELIXIS INC. Form: TABLET. Route: ORAL

full page →cabozantinib s-malate →fda approvals ↗

›Jan 15, 2019approval2760d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

›Jan 15, 2019approval2760d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

›Jan 15, 2019approval2760d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

full page →dulaglutide →fda approvals ↗

›Jan 15, 2019approval2760d agoZEGERID OTC (OMEPRAZOLE) — FDA approvalCovis Pharmaceuticals Inc (Inactive)

Sponsor: RILEY CONSUMER. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Jan 15, 2019approval2760d agoDEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) — FDA approvalMallinckrodt LLC

Sponsor: IMPAX LABS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Jan 16, 2019approval2759d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jan 16, 2019approval2759d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jan 17, 2019approval2758d agoALDACTAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

›Jan 18, 2019approval2757d agoONTRUZANT (TRASTUZUMAB-DTTB) — FDA approvalONTRUZANT

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: POWDER. Route: IV (INFUSION)

full page →ONTRUZANT →fda approvals ↗

›Jan 18, 2019approval2757d agoLIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INTRAVENOUS

full page →cemiplimab →fda approvals ↗

2752d ago

RIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION

full page →RIFADIN →fda approvals ↗

›Jan 23, 2019approval2752d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

full page →RIFATER →fda approvals ↗

›Jan 23, 2019approval2752d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL

full page →RIFADIN →fda approvals ↗

›Jan 24, 2019approval2751d agoSUBLIMAZE PRESERVATIVE FREE (FENTANYL CITRATE) — FDA approvalEffentora

Sponsor: RISING. Form: INJECTABLE. Route: INJECTION

full page →Effentora →fda approvals ↗

›Jan 24, 2019approval2751d agoFENTANYL CITRATE — FDA approvalEffentora

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →Effentora →fda approvals ↗

›Jan 25, 2019approval2750d agoDYNA-HEX 2 (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

Sponsor: XTTRIUM. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗

›Jan 25, 2019approval2750d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

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

full page →fda approvals ↗

›Jan 25, 2019approval2750d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

full page →fda approvals ↗

›Jan 25, 2019approval2750d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

full page →fda approvals ↗

›Jan 25, 2019approval2750d agoTIZANIDINE HYDROCHLORIDE — FDA approvalRiconpharma LLC

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

full page →fda approvals ↗

2747d ago

ALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

Sponsor: BAYER. Form: TABLET. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗

›Jan 28, 2019approval2747d agoPREZCOBIX (COBICISTAT) — FDA approvalGILEAD SCIENCES, INC.

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

full page →fda approvals ↗

›Jan 28, 2019approval2747d agoDIGOXIN — FDA approvalDIGOXIN

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →DIGOXIN →fda approvals ↗

›Jan 29, 2019approval2746d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

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

full page →fda approvals ↗

›Jan 29, 2019approval2746d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

›Jan 29, 2019approval2746d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

›Jan 29, 2019approval2746d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →guselkumab →fda approvals ↗

›Jan 31, 2019approval2744d agoSALONPAS (MENTHOL) — FDA approvalHisamitsu America Inc

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

full page →fda approvals ↗

›Feb 1, 2019approval2743d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

›Feb 1, 2019approval2743d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›Feb 1, 2019approval2743d agoXULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Feb 1, 2019approval2743d agoXULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Feb 2, 2019approval2742d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗

›Feb 2, 2019approval2742d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗

2740d ago

ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →fda approvals ↗

›Feb 4, 2019approval2740d agoANTARA (MICRONIZED) (FENOFIBRATE) — FDA approvalFENOFIBRATE

Sponsor: LUPIN. Form: CAPSULE. Route: ORAL

full page →FENOFIBRATE →fda approvals ↗

$NVS154.84+1.03%

$AVBP31.00-1.56%

$ABBV246.01+0.91%

$REGN774.68+1.84%

$ABBV246.01+0.91%

$PFE25.61+0.77%

$EXEL55.06+3.83%

$LLY1153.01+3.35%

$CPIX7.9000+1.67%

$ABBV246.01+0.91%

$GILD130.68-3.38%

$BMY63.70-3.32%

$AMRX18.62+0.76%