Non-specialty pipeline forecast as of June 2010

[chantell.reagan]

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



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

Abstral – PDUFA date extended 3 months

Afrezza – positive phase III non-inferiority data

apixaban – positive phase III data, study stopped early

avanafil – positive phase III data

Brilinta – FDA advisory board scheduled 7/10

Brinavess – EU recommends approval

Bydureon – mixed phase III data

canagliflozin – positive phase IIb data, with enrollment in phase III (new entry in DrugPipelineForecast)

clobazam – NDA expected to be submitted by end of year

Contrave – NDA accepted, FDA advisory board and PDUFA dates set

degludec – positive phase II data (new entry in DrugPipelineForecast)

dapagliflozin – positive phase III data

Dulera – FDA approved (removed from DrugPipelineForecast)

EGP-437(dexamethasone)- phase III trials initiated (new entry in DrugPipelineForecast)

Flutiform – update to NDA submission and Complete response letter

DM-1796 – NDA accepted

Ella – positive phase III data, FDA advisory board recommends drug

flibanserin – FDA advisory board unanimously recommends against drug

isavuconazole – expansion of phase III program with enrollment beginning 3Q10

Levadex – positive phase III data presented

LibiGel – positive phase III safety data

linagliptin- positive phase III data

lorcaserin – FDA advisory board scheduled

Luveniq – FDA advisory board canceled, priority review granted; PDUFA date scheduled

netupitan and palonosetron – entering phase III (new entry in DrugPipelineForecast)

naproxcinod – PDUFA date 7/24, but unlikey approval with FDA advisory board committee voting against

Neupro – positive phase III data

PecFent – EU recommends approval

Potiga – EU to review by end of month

RDEA594 – entering phase III (new entry in DrugPipelineForecast)

Rectogesic – Complete response letter received

rifamycin – 1st patient enrolled in phase III trial (new entry in DrugPipelineForecast)

Sativex – UK approval

sodium oxybate – FDA advisory board date scheduled

Staccato – positive phase III data; PDUFA date announced

taspoglutide – NDA filing delayed until 2014; REMS program initiated

TC-5214 – phase III initiated with expected NDA submission 2012

varespladib – 1st patient enrolled in pivotal phase III trial

Zevtera – EU confirms previous negative opinion

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