Non-specialty pipeline forecast as of April 2010

[chantell.reagan]

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



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

Acurox – FDA advisory board rejects drug

Afrezza – positive phase III data

asimadoline – FDA agrees on SPA

azilsartan medoxomil (TAK-491) – NDA submitted (new entry in DrugPipelineForecast)

buprenorphine – positive phase III data (new entry in DrugPipelineForecast)

Bydureon – increased cancer risk noted; response sent to FDA

Certriad – Complete response letter received

Contrave – mixed phase III data; NDA submitted

Cystoran (cysteamine) – in late phase III (new entry in DrugPipelineForecast)

Daxas – EU recommends drug

dutogliptin - positive phase III data

fidaxomicin- positive phase III data

DM-1796 – NDA submitted

Giazo – Complete response letter received (new entry in DrugPipelineForecast)

lixisenatide –positive phase III data (new entry in DrugPipelineForecast)

Lodotra – NDA submission expected by end of 2010

naproxcinod – upcoming FDA advisory board scheduled

Neupro – Complete response letter received

Ofirmev – resubmission expected within next month

Oralair – positive phase III data

Oravig – FDA approved (removed from DrugPipelineForecast)

Proellex – request to FDA to lift clinical hold

Pyramax –positive phase III comparative data (new entry in DrugPipelineForecast)

Restanza – SPA required by FDA

rilpivirine, emtricitabine, and tenofovir –NDA submission on track for 3Q10 (new entry in DrugPipelineForecast)

Sativex – positive phase III data

ser-120 – agreement with Allergan (new entry in DrugPipelineForecast)

Stedesa - Complete response letter received

taspoglutide – positive phase III data

telcagepant - published article in Lancet

QUAD HIV – first patient dosed in phase III trial (new entry in DrugPipelineForecast)

Vimovo – FDA approved (removed from DrugPipelineForecast)

Zenvia – positive phase III data

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