Non-specialty pipeline forecast as of February 2010

[chantell.reagan]

For your quick reference, please see the following publicized PDUFA review dates expected in March 2010:



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

aripiprazole (ALKS 9070) - expected to be in phase III in 2H10 (new entry in DrugPipelineForecast)

asimadoline - phase III to begin this month

Byetta LAR - PDUFA date extended 1 week

CPI-300 - Complete response letter received

Ereska - mixed phase III data

Exalgo - FDA approved (removed from DrugPipelineForecast)

Fablyn - positive phase III data published

fidaxomicin - positive phase III data with expected NDA submission 2H10

granisetron - upcoming PDUFA date 3/10

Horizant (previously known as Solzira) - Complete response letter received

ingenol mebutate - positive phase III data

isavuconazole - DSM recommends continuation of phase III trial (new entry in DrugPipelineForecast)

LibiGel - DSM recommends continuation of phase III trial with anticipated mid-2011 NDA submission

lorcaserin - NDA accepted by FDA and PDUFA date 4Q10

Luveniq - NDA submitted

Nuvigil - PDUFA for jet lag upcoming 3/10

Ofirmev (formerly known as Acetavance) - FDA puts NDA on hold

peramivir - sNDA submitted in Japan for pediatric use

Sativex - EU approval expected 1H10

Silenor - PDUFA date 3/10

sodium oxybate - positive phase III data

taspoglutide - expected NDA submission 2011

Xifaxan - recommended by FDA advisory board

Zuplenz - Complete response letter received

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

Related link: Everything you need to know about Non-Specialty pipeline between 10/09 and 3/10