Non-specialty pipeline forecast as of March 2010

[chantell.reagan]

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



Additionally, the following list represents non-specialty pipeline updates for March 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 scheduled; positive phase III abuse data

Afrezza – Complete response letter received; positive phase III data

apixaban – positive phase III data published

Brilinta – positive phase III data

Bydureon – Complete response letter received

Certriad – Complete response letter received

dapagiflozin + metformin – in phase III (new entry in DrugPipelineForecast)

Daxas – FDA advisory board scheduled

Dimebon – negative phase III data

eritoran – DMC recommends continuation of phase III trial (new entry in DrugPipelineForecast)

fentanyl SL spray – positive phase III data (new entry in DrugPipelineForecast)

granisetron – Complete Response letter received

Intermezzo – NDA resubmission expected by 4Q10

Lu AA24530 – phase III to begin (new entry in DrugPipelineForecast)

lurasidone – NDA accepted

methylnaltrexone – in phase III 2H2010 (new entry in DrugPipelineForecast)

mipomersen – phase III data published

MK-4305 – in phase III (new entry in DrugPipelineForecast)

mometasone/formoterol – positive phase III data presented

naproxcinod – FDA advisory board, PDUFA dates scheduled

Nuvigil – Complete response letter received

Pradaxa – positive phase III data

pramlintide/metreleptin – positive phase II data, advancing to phase III (new entry in DrugPipelineForecast)

PecFent – brand name change

Phleum Pratense allergy immunotherapy tablet (AIT) - grass – positive phase III data (new entry in DrugPipelineForecast)

Qnexa – NDA accepted and PDUFA scheduled

Restanza – FDA guidance requiring SPA with 2 clinical trials

Silenor – FDA approved (removed from DrugPipelineForecast)

tafluprost – in phase III (new entry in DrugPipelineForecast)

VIAject – NDA accepted and PDUFA date scheduled

vilazodone – NDA submitted

Vimovo – PDUFA date 4/10

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