Non-specialty pipeline forecast as of January 2010

[chantell.reagan]

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



Additionally, the following list represents non-specialty pipeline updates for January 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 to meet 4/10

Afrezza - PDUFA date delayed

avanafil - positive phase III data

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

Brilinta - positive phase III data

budesonide MMX - enrollment in phase III 60% complete (new entry in DrugPipelineForecast)

Eklira - focusing on BID dosing

Flutiform - Complete response letter received

Levadex - 2nd efficacy study not needed for NDA submission

Oleptro - FDA approved (removed from DrugPipelineForecast)

Prolacria - negative phase III data

Serada - 3rd phase III trial to begin by 4/10

Silenor - NDA resubmitted

Stedesa - PDUFA date delayed

TC-5214 - phase III to begin mid-2010 (new entry in DrugPipelineForecast)

tecarferin - FDA confirms correct regulatory pathway

VIAject - NDA submitted

Victoza - FDA approved (removed from DrugPipelineForecast)

Viviant - safety data published

WC 3016 - Complete response letter received (new entry in DrugPipelineForecast)

Xifaxan - FDA advisory board scheduled 2/10

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