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Reuters New Media
FDA fast-tracks Salix's diarrhea drug review

February 7, 2012
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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