Non-specialty pipeline forecast as of August 2009

[chantell.reagan]

In 3Q09, there are approximately 6 agents awaiting FDA review, in the areas of hypertension, diabetes, hypogonadism, vaginal atrophy, and osteoporosis. The following list represents non-specialty pipeline updates for August 2009 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)

arzoxifene – Lilly discontinues program (removed from DrugPipelineForecast)

Abstral – NDA submitted (new entry in DrugPipelineForecast)

ceftobiprole – FDA sends warning letter

Comfyde – Complete Response letter received

crofelemer – positive Phase III data/fast-track designation (new entry in DrugPipelineForecast)

defibrotide – negative Phase III results

Embeda - FDA approved (removed from DrugPipelineForecast)

Ereksa – negative Phase III data

Invega Sustenna – FDA approved (removed from DrugPipelineForecast)

Kynapid – SPA requirements

laninamivir - positive Phase III data (new entry in DrugPipelineForecast)

Levadex – positive Phase III data

LibiGel – review expected by 2011

Lipsovir- FDA approved (removed from DrugPipelineForecast)

Livalo - FDA approved (removed from DrugPipelineForecast)

Loramyc – FDA accepts NDA

lurasidone – positive Phase III data

Onglyza - FDA approved (removed from DrugPipelineForecast)

Pennsaid – PDUFA date set

Qutenza - PDUFA date extended

Saphris - FDA approved (removed from DrugPipelineForecast)

trazodone – response to FDA

Victoza – FDA review expected soon

Zelrix – positive Phase III data

Zenvia – positive Phase III data

Zenpep - FDA approved (removed from DrugPipelineForecast)

For more information, or to search additional drugs, please see DrugPipelineForecast