FDA Fast-Tracks Salix's Diarrhea Drug Review
February 13, 2012
The US Food and Drug Administration has granted priority review designation to crofelemer, an experimental treatment for HIV-associated diarrhea, the manufacturer Salix Pharmaceuticals Ltd. reported. Priority review status means the agency aims to complete its analysis of the application within six months, rather than the customary 10 months; FDA has set an action date of June 5 for the application. Salix -- based in Raleigh, N.C. -- holds North American and European rights to the drug; it has a supply agreement with India's Glenmark Pharmaceuticals Ltd.
This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.
Add Your Comment:
(Please note: Your name and comment will be public, and may even show up in
Internet search results. Be careful when providing personal information! Before
adding your comment, please read TheBody.com's Comment Policy.)