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FDA fast-tracks Salix's diarrhea drug review




 

Reuters NewMedia - February 7, 2012

* FDA grants priority review status for crofelemer * FDA sets action date of June 5 Feb 7 (Reuters) - Salix Pharmaceuticals Ltd said its experimental HIV-associated diarrhea drug will get a speedy review by U.S. health regulators.

The U.S. Food and Drug Administration granted priority review designation for Salix's marketing application and has set an action date of June 5 on the drug crofelemer.

Priority review status implies the agency would aim to complete its analysis of the application within six months, rather than the standard 10 months.

Raleigh, North Carolina-based Salix holds the North American and European rights to the drug and has a supply agreement with India's Glenmark Pharmaceuticals Ltd.

Salix shares closed at $48.55 on Monday on the Nasdaq.



 


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Information in this article was accurate in February 7, 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.