Non-specialty pipeline forecast as of August 2010

[chantell.reagan]

For your quick reference, please see the following publicized FDA advisory board and PDUFA review dates expected in September 2010:



Additionally, the following list represents non-specialty pipeline updates for August 2010 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)

Androxal – positive written feedback from FDA

Anturol – positive phase III data

Brinavess – late phase III trial delayed

Cogenzia – positive phase III data published

ella (ulipristal) – FDA approved (removed from DrugPipelineForecast)

gabapentin GR (SM-1796) – NDA accepted with PDUFA scheduled 1/11

Luveniq – Complete response letter received, requiring new clinical trial

mipomersen – positive phase III data, with expected NDA submission 1H2011

oxymorphone SR – NDA submission (new entry in DrugPipelineForecast)

perampanel (E2007) – positive phase III data (new entry in DrugPipelineForecast)

Potiga – FDA advisory board recommends drug, with PDUFA date on 11/30/10

Restanza – SPA reached for superiority trial

semagacestat – Lilly halts development (removed from DrugPipelineForecast)

Serada - SPA reached with FDA, results expected 4Q2011

sodium oxybate (JZP-6) – FDA advisory board votes against drug

Zelrix (sumatriptan patch) – phase III trials completed with expected launch 2012

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

Related link: Everything you need to know about Non-Specialty pipeline between 4/10 and 9/10