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.
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.