Non-specialty pipeline forecast as of July 2010

[chantell.reagan]

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



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

Afrezza - NDA resubmitted and PDUFA date set

Aricept 23mg - FDA approved (removed from DrugPipelineForecast)

Aricept (transdermal) - NDA submitted with expected review 2Q11

bardoxolone - entering into phase III (new entry in DrugPipelineForecast)

Brilinta - FDA advisory board recommends drug

Butrans - FDA approved (removed from DrugPipelineForecast)

calcitonin - clinical trials continue after DMC review, with data expected 4Q10

ceftaroline - FDA advisory board scheduled

Civanex - NDA submitted (new entry in DrugPipelineForecast)

Cogenzia - SPA submitted to FDA (new entry in DrugPipelineForecast)

Contrave - positive phase III data published

Corlux - beginning phase III trials (new entry in DrugPipelineForecast)

Daxas - approved in EU

epritirome - entering into phase III (new entry in DrugPipelineForecast)

Fortesta - FDA resubmission, with expected review in 6 months

Gestiva - NDA resubmission

LibiGel - new study initiated

Lodotra - positive phase III data

naproxcinod - Complete response letter received

Neupro - positive phase III data

Proellex - low-dose study approved by FDA

Qnexa - FDA advisory board votes against drug

rilpirivine - positive phase III data; NDA submitted

S/GSK1349572 - beginning phase III trials (new entry in DrugPipelineForecast)

tapentadol - positive phase III comparator data published

Zuplenz - FDA approved (removed from DrugPipelineForecast)

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