UPDATE 1-FDA fast-tracks Salix's diarrhea drug review

Tue Feb 7, 2012 7:28am EST

* 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.

Related Quotes and News

Company
Price
Related News
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.