Salix Submits Application for Crofelemer to FDA
The FDA has 60 days to review its filing and determine whether it is complete and ready for a more substantial review.
North Carolina-based gastroenterology specialty pharmaceutical company Salix Pharmaceuticals announced Wednesday that it has submitted Crofelemer, a potential treatment for HIV-associated diarrhea, to the FDA for approval.
The 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.
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