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calendar

30,247 catalysts · 10,642 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 2016-04-28×clear all

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type

approval10,642
device 510k5,000
grant4,728
8k filing3,086
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

phase 2 completion172

therapy area

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

Week of May 23, 2016

2

›May 27, 2016approval3729d agoVENOFER (IRON SUCROSE) — FDA approvalInternational Medication Systems Ltd

Sponsor: AM REGENT. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

›May 29, 2016approval3727d agoPROPOFOL — FDA approvalPROPOFOL

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →PROPOFOL →fda approvals ↗

Week of May 30, 2016

8

›May 31, 2016approval3725d agoVORICONAZOLE — FDA approvalGreenstone LLC

Sponsor: NOVEL LABS INC. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

›Jun 2, 2016approval

Week of Jun 6, 2016

14

›Jun 6, 2016approval3719d agoTYVASO (TREPROSTINIL) — FDA approvalUNITED THERAPEUTICS Corp

Sponsor: UNITED THERAP. Form: SOLUTION. Route: INHALATION

full page →fda approvals ↗

›Jun 6, 2016approval

Week of Jun 13, 2016

7

›Jun 13, 2016approval3712d agoVENOFER (IRON SUCROSE) — FDA approvalInternational Medication Systems Ltd

Sponsor: AM REGENT. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

›Jun 15, 2016approval

Week of Jun 20, 2016

7

›Jun 20, 2016approval3705d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAurobindo Pharma Ltd

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

full page →fda approvals ↗

›Jun 20, 2016approval

Week of Jun 27, 2016

4

›Jun 27, 2016approval3698d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

full page →fda approvals ↗

›Jun 28, 2016approval

Week of Jul 4, 2016

8

›Jul 5, 2016approval3690d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Jul 7, 2016approval

page 2 of 605

3723d ago

AUBAGIO (TERIFLUNOMIDE) — FDA approvalteriflunomide

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

full page →teriflunomide →fda approvals ↗

›Jun 2, 2016approval3723d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: ACTAVIS LABS FL INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jun 2, 2016approval3723d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

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

full page →hydrocodone bitartrate ER →fda approvals ↗

›Jun 2, 2016approval3723d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Jun 3, 2016approval3722d agoRYTARY (CARBIDOPA) — FDA approvalOrganon & Co.

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

full page →fda approvals ↗

›Jun 3, 2016approval3722d agoLETROZOLE — FDA approvalHikma Pharmaceuticals Plc

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

full page →fda approvals ↗

›Jun 5, 2016approval3720d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

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

full page →tedizolid phosphate →fda approvals ↗

3719d ago

DURAMORPH PF (MORPHINE SULFATE) — FDA approvalKapanol

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →Kapanol →fda approvals ↗

›Jun 7, 2016approval3718d agoLANSOPRAZOLE — FDA approvallansoprazole DR

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

full page →lansoprazole DR →fda approvals ↗

›Jun 7, 2016approval3718d agoSTIVARGA (REGORAFENIB) — FDA approvalBayer AG

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

full page →fda approvals ↗

›Jun 8, 2016approval3717d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL

full page →ivacaftor →fda approvals ↗

›Jun 8, 2016approval3717d agoPEPCID AC (FAMOTIDINE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jun 8, 2016approval3717d agoCEREZYME (IMIGLUCERASE) — FDA approvalimiglucerase

Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION

full page →imiglucerase →fda approvals ↗

›Jun 8, 2016approval3717d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

full page →fda approvals ↗

›Jun 9, 2016approval3716d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

Sponsor: MICRO LABS. Form: TABLET. Route: ORAL

full page →LOSARTAN POTASSIUM →fda approvals ↗

›Jun 9, 2016approval3716d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

full page →fda approvals ↗

›Jun 9, 2016approval3716d agoMEROPENEM — FDA approvalMEROPENEM

Sponsor: ACS DOBFAR SPA. Form: INJECTABLE. Route: INJECTION

full page →MEROPENEM →fda approvals ↗

›Jun 10, 2016approval3715d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →LOSARTAN POTASSIUM →fda approvals ↗

›Jun 10, 2016approval3715d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

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

full page →LOSARTAN POTASSIUM →fda approvals ↗

›Jun 10, 2016approval3715d agoLOSARTAN POTASSIUM — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗

3710d ago

HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Jun 15, 2016approval3710d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

full page →taliglucerase alfa →fda approvals ↗

›Jun 16, 2016approval3709d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

›Jun 17, 2016approval3708d agoLACTATED RINGER'S IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalBaxter Healthcare Corp

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

full page →fda approvals ↗

›Jun 17, 2016approval3708d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

›Jun 17, 2016approval3708d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗

3705d ago

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ZYDUS PHARMS USA INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Jun 21, 2016approval3704d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

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

full page →VIGABATRIN →fda approvals ↗

›Jun 21, 2016approval3704d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

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

full page →VIGABATRIN →fda approvals ↗

›Jun 24, 2016approval3701d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAurobindo Pharma Ltd

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

full page →fda approvals ↗

›Jun 24, 2016approval3701d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAurobindo Pharma Ltd

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

full page →fda approvals ↗

›Jun 24, 2016approval3701d agoDEMEROL (MEPERIDINE HYDROCHLORIDE) — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

3697d ago

IMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

full page →fda approvals ↗

›Jun 30, 2016approval3695d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

Sponsor: ABBVIE INC. Form: VIAL

full page →adalimumab →fda approvals ↗

›Jun 30, 2016approval3695d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

Sponsor: ACTAVIS LABS FL INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

3688d ago

CEREZYME (IMIGLUCERASE) — FDA approvalimiglucerase

Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION

full page →imiglucerase →fda approvals ↗

›Jul 7, 2016approval3688d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: RUBICON RESEARCH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Jul 7, 2016approval3688d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Jul 7, 2016approval3688d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Jul 7, 2016approval3688d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Jul 7, 2016approval3688d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

Sponsor: OSMOTICA PHARM US. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Jul 7, 2016approval3688d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: SUN PHARM. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

$ABBV249.50+0.61%

$UTHR525.28-0.83%

$OGN13.65+0.22%

$VERX12.12-0.16%

$KVUE18.96-0.37%

$IGC0.2670+0.41%

$KVUE18.96-0.37%

$NVS155.21-1.01%

$NVS155.21-1.01%

$NVS155.21-1.01%

$PFE26.63-1.57%

$ABBV249.50+0.61%

$ABBV249.50+0.61%

$IGC0.2670+0.41%