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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update

UNITED STATES: FDA Fast-Tracks Salix's Diarrhea Drug Review


Reuters (02.07.12) - Monday, 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.


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Information in this article was accurate in February 13, 2012. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.