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calendar

18,993 catalysts · 18,987 approval · 5,720 phase readout · 5,000 device 510k · 4,728 grant · 2,952 8k filing · 2,000 device pma

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approval18,987
phase readout5,720
device 510k5,000
grant4,728
8k filing2,952
device pma2,000
device recall

2,000

device adverse event1,000

therapy area

Ophthalmology5

Week of Mar 24, 2014

3

›Mar 28, 2014approval4515d agoTOPAMAX SPRINKLE (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

›Mar 28, 2014approval4515d agoTOPAMAX (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

›Mar 28, 2014approval4515d agoSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) — FDA approvalmethylprednisolone sodium succinate

Sponsor: PHARMACIA AND UPJOHN. Form: INJECTABLE. Route: INJECTION

full page →methylprednisolone sodium succinate →fda approvals ↗

Week of Mar 31, 2014

10

›Mar 31, 2014approval4512d agoCAPRELSA (VANDETANIB) — FDA approvalvandetanib

Sponsor: GENZYME CORP. Form: TABLET. Route: ORAL

full page →vandetanib →fda approvals ↗

›Mar 31, 2014approval

Week of Apr 7, 2014

6

›Apr 7, 2014approval4505d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

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

full page →fda approvals ↗

›Apr 7, 2014approval

Week of Apr 14, 2014

18

›Apr 14, 2014approval4498d agoDOXIL (LIPOSOMAL) (DOXORUBICIN HYDROCHLORIDE) — FDA approvalDoxil

Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE, LIPOSOMAL. Route: INJECTION

full page →Doxil →fda approvals ↗

›Apr 16, 2014approval

Week of Apr 21, 2014

6

›Apr 21, 2014approval4491d agoMETHYLPREDNISOLONE ACETATE — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗

›Apr 22, 2014approval

Week of Apr 28, 2014

7

›Apr 28, 2014approval4484d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: INDIVIOR. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Apr 28, 2014approval

page 139 of 380

4512d ago

TRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

full page →tramadol hydrochloride ER →fda approvals ↗

›Apr 3, 2014approval4509d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

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

full page →VIGABATRIN →fda approvals ↗

›Apr 3, 2014approval4509d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

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

full page →VIGABATRIN →fda approvals ↗

›Apr 4, 2014approval4508d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

›Apr 4, 2014approval4508d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

›Apr 4, 2014approval4508d agoCLEOCIN T (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: GEL. Route: TOPICAL

full page →CLEOCIN →fda approvals ↗

›Apr 4, 2014approval4508d agoCLEOCIN (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: SWAB. Route: TOPICAL

full page →CLEOCIN →fda approvals ↗

›Apr 4, 2014approval4508d agoCLEOCIN T (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: LOTION. Route: TOPICAL

full page →CLEOCIN →fda approvals ↗

›Apr 4, 2014approval4508d agoSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) — FDA approvalmethylprednisolone sodium succinate

Sponsor: PHARMACIA AND UPJOHN. Form: INJECTABLE. Route: INJECTION

full page →methylprednisolone sodium succinate →fda approvals ↗

4505d ago

VFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

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

full page →fda approvals ↗

›Apr 7, 2014approval4505d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

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

full page →fda approvals ↗

›Apr 7, 2014approval4505d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAurobindo Pharma Ltd

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

full page →fda approvals ↗

›Apr 8, 2014approval4504d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

full page →fda approvals ↗

›Apr 11, 2014approval4501d agoHUMATROPE (SOMATROPIN) — FDA approvalEMD Serono Inc

Sponsor: LILLY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

4496d ago

METHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

›Apr 16, 2014approval4496d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

›Apr 16, 2014approval4496d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: IMPAX LABS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Apr 16, 2014approval4496d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

›Apr 16, 2014approval4496d agoOXYCONTIN (OXYCODONE HYDROCHLORIDE) — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: PURDUE PHARMA LP. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

›Apr 16, 2014approval4496d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

›Apr 16, 2014approval4496d agoBUTRANS (BUPRENORPHINE) — FDA approvalBUTRANS

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

full page →BUTRANS →fda approvals ↗

›Apr 16, 2014approval4496d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

›Apr 16, 2014approval4496d agoMS CONTIN (MORPHINE SULFATE) — FDA approvalKapanol

Sponsor: PURDUE PHARMA LP. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →Kapanol →fda approvals ↗

›Apr 16, 2014approval4496d agoNUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

Sponsor: COLLEGIUM PHARM INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tapentadol hydrochloride ER →fda approvals ↗

›Apr 17, 2014approval4495d agoKESIMPTA (OFATUMUMAB) — FDA approvalKESIMPTA

Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →KESIMPTA →fda approvals ↗

›Apr 17, 2014approval4495d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

›Apr 17, 2014approval4495d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

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

full page →naltrexone ER →fda approvals ↗

›Apr 18, 2014approval4494d agoTROKENDI XR (TOPIRAMATE) — FDA approvalSUPERNUS PHARMACEUTICALS, INC.

Sponsor: SUPERNUS PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Apr 18, 2014approval4494d agoTROKENDI XR (TOPIRAMATE) — FDA approvalSUPERNUS PHARMACEUTICALS, INC.

Sponsor: SUPERNUS PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Apr 18, 2014approval4494d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →Kapanol →fda approvals ↗

›Apr 18, 2014approval4494d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

4490d ago

HEPARIN SODIUM — FDA approvalHEPARIN SODIUM

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →HEPARIN SODIUM →fda approvals ↗

›Apr 22, 2014approval4490d agoHEPARIN SODIUM — FDA approvalHEPARIN SODIUM

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →HEPARIN SODIUM →fda approvals ↗

›Apr 23, 2014approval4489d agoADRENACLICK (EPINEPHRINE) — FDA approvalViatris Inc

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

full page →fda approvals ↗

›Apr 23, 2014approval4489d agoJUXTAPID (LOMITAPIDE MESYLATE) — FDA approvalChiesi USA Inc

Sponsor: CHIESI. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Apr 24, 2014approval4488d agoZIPRASIDONE HYDROCHLORIDE — FDA approvalLupin Ltd

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

full page →fda approvals ↗

4484d ago

SUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: INDIVIOR. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Apr 28, 2014approval4484d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: INDIVIOR. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Apr 29, 2014approval4483d agoZIRGAN (GANCICLOVIR) — FDA approvalganciclovir

Sponsor: BAUSCH AND LOMB. Form: GEL. Route: OPHTHALMIC

full page →ganciclovir →fda approvals ↗

›Apr 30, 2014approval4482d agoCARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER (NICARDIPINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: CHIESI. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

›Apr 30, 2014approval4482d agoEPIPEN E Z PEN (EPINEPHRINE) — FDA approvaladrenaline

Sponsor: VIATRIS. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →adrenaline →fda approvals ↗

›Apr 30, 2014approval4482d agoACTIQ (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TROCHE/LOZENGE. Route: TRANSMUCOSAL

full page →fda approvals ↗

$INDV40.10-2.17%

$PFE26.20+1.51%

$VERX11.57-1.95%

$PFE26.20+1.51%

$PFE26.20+1.51%

$IGC0.2670+0.41%

$AMRX18.07-2.11%

$COLL29.11-18.55%

$IGC0.2670+0.41%

$NVS154.21-0.15%

$SUPN46.76-0.32%

$SUPN46.76-0.32%

$AMRX18.07-2.11%

$PFE26.20+1.51%

$VTRS16.29-7.71%

$PFE26.20+1.51%

$ALKS49.53+1.10%

$INDV40.10-2.17%

$INDV40.10-2.17%

$BLCO16.35-2.45%

$AMRX18.07-2.11%

$VTRS16.29-7.71%