Non-specialty pipeline forecast as of December 2009

[chantell.reagan]

As we enter a new year there is much FDA activity expected for non-specialty pipeline. For your quick reference, please see the following publicized PDUFA review dates expected in January 2010:



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

almorexant - mixed phase III data

Aricept SR - NDA accepted

Cangrelor - mixed phase III data

Ciltyri (eplivanserin) - drug development discontinued (removed from DrugPipelineForecast)

darusentan - negative phase III data (discontinuation likely)

dutogliptin - in phase III (new entry in DrugPipelineForecast)

Dyloject- NDA submitted

fluticasone/642444 - in phase III (new entry in DrugPipelineForecast)

indacaterol – approved in EU

ingenol mebutate - positive phase III data

lorcaserin - NDA submitted

Nuvigil - PDUFA date extended

Oralair Grasses - soon to enter phase III in US (new entry in DrugPipelineForecast)

Qnexa - NDA submitted

retigabine - NDA accepted

Silenor - Complete response letter received

sodium oxybate - NDA submitted

Staccato - NDA submitted

taspoglutide – positive phase III data

Victoza - FDA review expected soon

Zenvia – positive phase III data

Zevtera - Complete response letter received

Zyprexa Relprevv - FDA approved (removed from DrugPipeline Forecast)

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

Related link: Everything you need to know about Non-Specialty pipeline between 10/09 and 3/10

[chantell.reagan]

Of note, FDA has delayed the review of Afresa (now known as Afrezza), as it needs more time to complete the inspection of the insulin manufacturing facility. The new PDUFA date has not been released yet. (Source:News article 1/10)