Non-specialty pipeline forecast as of September 2009

[chantell.reagan]

In 4Q09, there are approximately 22 agents awaiting FDA review, in the areas of hypertension, diabetes, hypogonadism, antiinfectives, oncology, pain management, respiratory, epilepsy, insomnia, restless leg syndrome and GERD. The following list represents non-specialty pipeline updates for September 2009 from DrugPipelineForecast. Please click on the product name to view update for individual products. To access DrugPipelineForecast, you must be a registered user of DrugManagementForum (click here to register)

Acurox - no new clinical data needed

alogliptin/pioglitazone - Complete response letter received

Bepreve - FDA approved (removed from DrugPipelineForecast)

Brilinta - positive phase III data

Ciltyri - Complete response letter received

dabigatran - positive phase III data

Daxas - positive phase III data

Exalgo - FDA advisory board recommends drug

Flutiform - FDA requiring additional data

Fortesta - NDA being reviewed (new entry in DrugPipelineForecast)

indacaterol - positive phase III data

Intuniv – FDA approved (removed from DrugPipelineForecast)

laninamivir - positive phase III data (new entry in DrugPipelineForecast)

Lodotra - positive phase III data

lorcaserin - positive phase III data

lurasidone - positive phase III data

Metozolv - FDA approved (removed from DrugPipelineForecast)

Nebido - PDUFA date extended

OxyContin (reformulated) - FDA advisory board recommends drug (new entry in DrugPipelineForecast)

pimavanserin - negative phase III data

Pradaxa - positive phase III data

Qnexa - positive phase III data

rifaximin - positive phase III data

rolofylline - negative phase III data (new entry in DrugPipelineForecast)

soluble beta-glucan (SBG) - phase III trial initiated (new entry in DrugPipelineForecast)

trazodone - PDUFA date scheduled

Vibativ - FDA approved (removed from DrugPipelineForecast)

Victoza - PDUFA date delayed

Vimovo - NDA accepted by FDA

Viviant - positive phase III data

For more information, or to search additional drugs, please see DrugPipelineForecast