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Salix Submits FDA application for Crofelemer

RALEIGH, N.C. (AP) - Salix Pharmaceuticals Ltd. said Wednesday that it submitted Crofelemer, its potential treatment for HIV-associated diarrhea, to the Food and Drug Administration for approval.

The Raleigh, N.C., company said the FDA has 60 days to review its filing and determine whether it is complete and ready for a more substantial review.

Salix develops pharmaceutical products for gastrointestinal diseases. It has an exclusive license to Crofelemer's HIV-associated diarrhea indication as well as indications for pediatric diarrhea and acute infectious diarrhea in North America, several European countries and Japan.

Salix also makes Xifaxan, which treats traveler's diarrhea and neurological problems associated with liver failure.

Company shares rose 29 cents to $43.47 Wednesday morning, as broader trading indexes slipped.


Posted: December 2011