Non-specialty pipeline forecast as of July 2009

[chantell.reagan]

In 3Q09, there are approximately 9 agents awaiting FDA review, in the areas of hypertension, pain management, diabetes, hypogonadism, vaginal atrophy, osteoporosis and dermatologic antiviral. The following list represents non-specialty pipeline updates for July 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)

Acetavance - priority review granted, PDUFA date set

Acurox - Complete Response letter received

alogliptin and pioglitazone - PDUFA date changed

Aricept/SR - NDAs expected to be submitted soon (new entry in DrugPipelineForecast)

Byetta LAR - positive Phase III data, NDA accepted

Ciltyri - in Phase III (new entry in DrugPipelineForecast)

Contrave - positive Phase III data

dalcetriapib - in Phase III (new entry in DrugPipelineForecast)

Daxas - NDA submitted

Dimebon - mixed Phase III data, Phase III started for Huntingdon's disease

Effient - FDA approved (removed from DrugPipelineForecast)

estradiol valerate and dienogest - NDA submitted (new entry in DrugPipelineForecast)

glycopyrronium - pivotal Phase III trial starts

granisetron - new PDUFA date set, NDA accepted

Ketotransdel - in Phase III (new entry in DrugPipelineForecast)

MGX006 - NDA accepted

mometasone/formoterol - NDA submitted and accepted

Multaq - FDA approved (removed from DrugPipelineForecast)

Onsolis - FDA approved (removed from DrugPipelineForecast)

Priligy - in Phase III (new entry in DrugPipelineForecast)

Qutenza - new PDUFA date set

Remoxy - resubmission slated for mid-2010

Saphris - positive Phase III data and recommendation from FDA advisory board

Serdolect - Complete Response letter received

Silenor - NDA accepted

Sumavel DosePro - FDA approved (removed from DrugPipelineForecast)

tecarfarin - negative Phase III results (new entry in DrugPipelineForecast)

terbinafine nail lacquer - search for marketing partner (new entry in DrugPipelineForecast)

Testosterone MD lotion - NDA expected to be submitted in 2009 (new entry in DrugPipelineForecast)

trazodone - Complete Response letter received

Vimovo - NDA submitted

Xarelto - resubmission expected by end of 2009

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