Non-specialty pipeline forecast as of May 2010

[chantell.reagan]

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



Additionally, the following list represents non-specialty pipeline updates for May 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 – NDA submission expected early 2011

Afrezza – FDA decision expected by early 2011

aleglitazar – phase III trials began 3/10 (new entry in DrugPipelineForecast)

apricitabine (ATC) – drug program discontinued (removed from DrugPipelineForecast)

Axanum – FDA rejected NDA, complete response letter is being evaluated by AZ

azilsartan – positive phase III comparative data

Brinavess – positive phase III data

Bydureon – PDUFA date rescheduled

CIP-tramadol – FDA approved (removed from DrugPipelineForecast)

Daxas – FDA advisory board votes against drug

Duexa – NDA accepted (new entry in DrugPipelineForecast)

flibanserin – mixed phase III data

Horizant – FDA requesting preclinical data

Levadex – phase III trials completed with NDA submission expected 1H2011

linaclotide – positive phase III data

Luveniq – FDA advisory board date scheduled

mirabegron (YM178) – NDA submission expected 2H2010 (new entry in DrugPipelineForecast)

naproxcinod – FDA advisory board votes against drug

Natazia – FDA approved (removed from DrugPipelineForecast)

Nestorone/estrogen ethynylestradiol – phase III trials began 3/10 (new entry in DrugPipelineForecast)

NX-1207 positive phase III data (new entry in DrugPipelineForecast)

Ofirmev – Complete response sent to FDA; PDUFA date scheduled

Sprix – FDA approved (removed from DrugPipelineForecast)

TDT 067 – initiation of phase III (new entry in DrugPipelineForecast)

Qnexa – phase III data to be presented

QVA149/glycopyrronium – initiated phase III trials

udenafil – in phase III (new entry in DrugPipelineForecast)

ulipristal – FDA advisory board scheduled (new entry in DrugPipelineForecast)

vilazodone – NDA accepted

Zenvia – Complete response sent to FDA; priority review granted with PDUFA date scheduled

Zerenex – phase III begins (new entry in 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