Non-specialty pipeline forecast as of November 2009

[chantell.reagan]

As we await the end of 2009, there is much FDA activity expected for non-specialty pipeline. For your quick reference, please see the following publicized PDUFA review dates expected in December:



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

Abstral – FDA accepts NDA

Acapodene – Complete response letter received

Acetavance – PDUFA date extended

AMR101 – phase III to begin soon (new entry in DrugPipelineForecast)

avanafil – positive phase III data

Aveed – Complete response letter received

Brilinta – positive phase III data, NDA submitted

Bronchitol – started new phase III trial

Dimebon – phase III started in Alzheimers

d-tagatose – positive phase III data (new entry in DrugPipelineForecast)

Exalgo – PDUFA date extended

Ferriprox – NDA submitted early 2009 (new entry in DrugPipelineForecast)

flibanserin – positive phase III data (new entry in DrugPipelineForecast)

Flublok – not recommended by FDA advisory board

Gencaro – FDA grants fast-track designation

indacaterol – positive phase III data

Kynapid – confirmatory phase III trial begins

linaclotide – positive phase III data

Luveniq – positive phase III data

Lysteda – FDA approved (removed from DrugPipelineForecast)

mipomersen – positive phase III data

mometasone/formoterol – positive phase III data

naproxcinod – NDA accepted by FDA

omeprazole/aspirin – phase III trials initiated (new entry in DrugPipelineForecast)

Pennsaid – FDA approved (removed from DrugPipelineForecast)

Pradaxa – positive phase III data

Prevnar-13 – recommended by FDA advisory board

Qutenza – FDA approved (removed from DrugPipelineForecast)

Resolor – approved in EU

retigabine – NDA submitted

Sativex – positive phase III data (new entry in DrugPipelineForecast)

SCH 530348 – phase III enrollment completed (new entry in DrugPipelineForecast)

Solzira – PDUFA date extended

Staccato – positive phase III data

taspoglutide – positive phase III data

Xarelto – positive phase III data

Zegerid OTC - FDA approved (removed from DrugPipelineForecast)

Zenvia – positive phase III data

Zevtera - positive phase III data

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