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calendar

30,328 catalysts · 10,683 approval · 5,000 device 510k · 4,728 grant · 3,126 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2016-04-20×clear all

type

approval10,683
device 510k5,000
grant4,728
8k filing3,126
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 May 2, 2016

›May 5, 2016approval3751d agoPEPCID AC (FAMOTIDINE) — FDA approvalKenvue Inc.

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

full page →fda approvals ↗

›May 6, 2016approval3750d agoSYNJARDY (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →SYNJARDY →fda approvals ↗

›May 6, 2016approval3750d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

full page →fda approvals ↗

›May 6, 2016approval3750d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

full page →fda approvals ↗

›May 6, 2016approval3750d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗

Week of May 9, 2016

›May 9, 2016approval3747d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

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

full page →fda approvals ↗

›May 9, 2016approval

Week of May 16, 2016

›May 17, 2016approval3739d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

›May 18, 2016approval

Week of May 23, 2016

›May 23, 2016approval3733d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

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

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

›May 23, 2016approval

Week of May 30, 2016

›May 31, 2016approval3725d agoVORICONAZOLE — FDA approvalGreenstone LLC

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

full page →fda approvals ↗

›Jun 2, 2016approval

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page 2 of 607

3747d ago

DICLOFENAC SODIUM — FDA approvalDICLOFENAC SODIUM

Sponsor: AUROBINDO PHARMA USA. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →DICLOFENAC SODIUM →fda approvals ↗

›May 9, 2016approval3747d agoPONSTEL (MEFENAMIC ACID) — FDA approvalAvion Pharmaceuticals LLC

Sponsor: AVION PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›May 10, 2016approval3746d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: AMNEAL PHARMS NY. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›May 12, 2016approval3744d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

›May 12, 2016approval3744d agoKARBINAL ER (CARBINOXAMINE MALEATE) — FDA approvalAYTU BIOPHARMA, INC

Sponsor: AYTU. Form: SUSPENSION, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›May 13, 2016approval3743d agoQUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: NEXTWAVE. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

3738d ago

EPIPEN E Z PEN (EPINEPHRINE) — FDA approvaladrenaline

Sponsor: VIATRIS. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →adrenaline →fda approvals ↗

›May 18, 2016approval3738d agoADRENACLICK (EPINEPHRINE) — FDA approvalViatris Inc

Sponsor: IMPAX. Form: INJECTABLE. Route: INTRAMUSCULAR, SUBCUTANEOUS

full page →fda approvals ↗

›May 18, 2016approval3738d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

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

full page →(ivacaftor + lumacaftor) →fda approvals ↗

›May 18, 2016approval3738d agoSUBLIMAZE PRESERVATIVE FREE (FENTANYL CITRATE) — FDA approvalEffentora

Sponsor: RISING. Form: INJECTABLE. Route: INJECTION

full page →Effentora →fda approvals ↗

›May 18, 2016approval3738d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

full page →atezolizumab →fda approvals ↗

›May 18, 2016approval3738d agoLINZESS (LINACLOTIDE) — FDA approvallinaclotide

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →linaclotide →fda approvals ↗

›May 18, 2016approval3738d agoHALDOL (HALOPERIDOL DECANOATE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

›May 19, 2016approval3737d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

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

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

›May 19, 2016approval3737d agoATORVASTATIN CALCIUM — FDA approvalSciegen Pharmaceuticals Inc

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

full page →fda approvals ↗

›May 19, 2016approval3737d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

Sponsor: ALKERMES. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →naltrexone ER →fda approvals ↗

›May 19, 2016approval3737d agoFENTORA (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TABLET. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

›May 19, 2016approval3737d agoKINERET (ANAKINRA) — FDA approvalSobi Inc

Sponsor: BIOVITRUM AB. Form: VIAL. Route: SUBCUTANEOUS

full page →fda approvals ↗

›May 20, 2016approval3736d agoCLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗

›May 20, 2016approval3736d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

full page →fda approvals ↗

›May 20, 2016approval3736d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

Sponsor: ALKERMES. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →naltrexone ER →fda approvals ↗

›May 20, 2016approval3736d agoCOMETRIQ (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

Sponsor: EXELIXIS. Form: CAPSULE. Route: ORAL

full page →cabozantinib s-malate →fda approvals ↗

3733d ago

JUXTAPID (LOMITAPIDE MESYLATE) — FDA approvalChiesi USA Inc

Sponsor: CHIESI. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›May 24, 2016approval3732d agoRECLAST (ZOLEDRONIC ACID) — FDA approvalZOLEDRONIC ACID

Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

full page →ZOLEDRONIC ACID →fda approvals ↗

›May 24, 2016approval3732d agoROGAINE (FOR WOMEN) (MINOXIDIL) — FDA approvalVeradermics, Inc

Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗

›May 24, 2016approval3732d agoWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

full page →fda approvals ↗

›May 24, 2016approval3732d agoVORICONAZOLE — FDA approvalVORICONAZOLE

Sponsor: CADILA. Form: TABLET. Route: ORAL

full page →VORICONAZOLE →fda approvals ↗

›May 24, 2016approval3732d agoVORICONAZOLE — FDA approvalVORICONAZOLE

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

full page →VORICONAZOLE →fda approvals ↗

›May 25, 2016approval3731d agoALLI (ORLISTAT) — FDA approvalH2-Pharma LLC

Sponsor: HALEON US HOLDINGS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›May 25, 2016approval3731d agoAZITHROMYCIN — FDA approvalPFIZER INC

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

full page →fda approvals ↗

›May 26, 2016approval3730d agoPROBUPHINE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: REACX PHARMS. Form: IMPLANT. Route: IMPLANTATION

full page →fda approvals ↗

›May 26, 2016approval3730d agoFENTANYL CITRATE — FDA approvalEffentora

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →Effentora →fda approvals ↗

›May 27, 2016approval3729d agoQUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: NEXTWAVE. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›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 ↗

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 ↗

$KVUE19.05+0.11%

$ABBV249.50+0.61%

$NVS155.21-1.01%

$IGC0.2670+0.41%

$BMY63.75-1.68%

$CPIX8.0500+3.34%

$AYTU2.2300-0.89%

$ABBV249.50+0.61%

$VERX12.23+0.78%

$COLL25.98-4.49%

$VTRS16.20-0.49%

$ABBV249.50+0.61%

$PFE26.63-1.57%

$ALKS49.21-0.38%

$MANE108.95-1.63%

$VERX12.23+0.78%

$ALKS49.21-0.38%

$EXEL51.33-3.08%

$PFE26.63-1.57%

$IGC0.2670+0.41%

$COLL25.98-4.49%

$OGN13.65+0.22%