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calendar

29,094 catalysts · 9,606 approval · 5,000 device 510k · 4,728 grant · 2,629 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2017-08-21×clear all

type

approval9,606
device 510k5,000
grant4,728
8k filing2,629
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

pdufa347

earnings317

therapy area

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

Week of Feb 19, 2018

›Feb 21, 2018approval3086d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

›Feb 21, 2018approval3086d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Week of Feb 26, 2018

›Feb 26, 2018approval3081d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL

full page →ondansetron hydrochloride CR →fda approvals ↗

›Feb 26, 2018approval

Week of Mar 5, 2018

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval

Week of Mar 12, 2018

›Mar 13, 2018approval3066d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

›Mar 13, 2018approval

Week of Mar 19, 2018

›Mar 20, 2018approval3059d agoILUMYA (TILDRAKIZUMAB-ASMN) — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: SUN PHARMA GLOBAL. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Mar 20, 2018approval

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page 7 of 582

3081d ago

ONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL

full page →ondansetron hydrochloride CR →fda approvals ↗

›Feb 26, 2018approval3081d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL

full page →ondansetron hydrochloride CR →fda approvals ↗

›Feb 26, 2018approval3081d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Feb 28, 2018approval3079d agoOMEPRAZOLE — FDA approvalomeprazole DR

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

full page →omeprazole DR →fda approvals ↗

›Mar 1, 2018approval3078d agoIOPIDINE (APRACLONIDINE HYDROCHLORIDE) — FDA approvalHARROW, INC.

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

full page →fda approvals ↗

›Mar 1, 2018approval3078d agoIOPIDINE (APRACLONIDINE HYDROCHLORIDE) — FDA approvalHARROW, INC.

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

full page →fda approvals ↗

›Mar 1, 2018approval3078d agoDEPO-SUBQ PROVERA 104 (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

Sponsor: PFIZER. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →medroxyprogesterone acetate →fda approvals ↗

3074d ago

OPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

Sponsor: INDIVIOR. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

full page →buprenorphine LA →fda approvals ↗

›Mar 6, 2018approval3073d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

›Mar 6, 2018approval3073d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

›Mar 6, 2018approval3073d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

›Mar 6, 2018approval3073d agoALDACTONE (SPIRONOLACTONE) — FDA approvalALDACTONE

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →ALDACTONE →fda approvals ↗

›Mar 6, 2018approval3073d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

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

full page →fda approvals ↗

›Mar 7, 2018approval3072d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

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

full page →fda approvals ↗

›Mar 7, 2018approval3072d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

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

full page →ondansetron hydrochloride CR →fda approvals ↗

›Mar 7, 2018approval3072d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

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

full page →ondansetron hydrochloride CR →fda approvals ↗

›Mar 7, 2018approval3072d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →ondansetron hydrochloride CR →fda approvals ↗

›Mar 7, 2018approval3072d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →ondansetron hydrochloride CR →fda approvals ↗

›Mar 7, 2018approval3072d agoONDANSETRON — FDA approvalondansetron ODT

Sponsor: AUROBINDO PHARMA. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →ondansetron ODT →fda approvals ↗

›Mar 7, 2018approval3072d agoONDANSETRON — FDA approvalSandoz Inc

Sponsor: BARR. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

›Mar 7, 2018approval3072d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

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

full page →ondansetron hydrochloride CR →fda approvals ↗

›Mar 8, 2018approval3071d agoCINACALCET HYDROCHLORIDE — FDA approvalCINACALCET HYDROCHLORIDE

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

full page →CINACALCET HYDROCHLORIDE →fda approvals ↗

›Mar 9, 2018approval3070d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

3066d ago

TECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

full page →atezolizumab →fda approvals ↗

›Mar 15, 2018approval3064d agoCLEOCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) — FDA approvalclindamycin hydrochloride

Sponsor: PFIZER. Form: CAPSULE. Route: ORAL

full page →clindamycin hydrochloride →fda approvals ↗

›Mar 15, 2018approval3064d agoAMJEVITA (ADALIMUMAB-ATTO) — FDA approvalAMJEVITA

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

full page →AMJEVITA →fda approvals ↗

›Mar 16, 2018approval3063d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

full page →certolizumab pegol →fda approvals ↗

3059d ago

TEGRETOL-XR (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗

›Mar 20, 2018approval3059d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

›Mar 20, 2018approval3059d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

›Mar 20, 2018approval3059d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

full page →certolizumab pegol →fda approvals ↗

›Mar 21, 2018approval3058d agoNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE →fda approvals ↗

›Mar 21, 2018approval3058d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: WES PHARMA INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Mar 22, 2018approval3057d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

full page →tocilizumab →fda approvals ↗

›Mar 22, 2018approval3057d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →tocilizumab →fda approvals ↗

$BMY65.31+0.69%

$AMRX18.32-0.97%

$RDY11.85+0.17%

$HROW38.49-0.71%

$PFE25.01+0.40%

$BMY65.31+0.69%

$RDY11.85+0.17%

$BMY65.31+0.69%

$HROW38.49-0.71%

$BMY65.31+0.69%

$INDV40.10-2.17%

$ABBV250.94-2.51%

$PFE25.01+0.40%

$RDHL0.7390+6.64%

$NVS156.15-1.45%

$AMGN385.16-0.64%

$PFE25.01+0.40%

$NVS156.15-1.45%

$IGC0.2670+0.41%