FDA Requests Extension to Review Salix Pharmaceuticals, Ltd. Drug

Published: May 01, 2012

Triangle Business Journal by Lauren K. Ohnesorge, Staff Writer

Raleigh-based Salix Pharmaceuticals said Monday that the FDA has extended its review period for a drug that Salix wants to market as a diarrhea relief medication for HIV and AIDS patients.

The new deadline for reviewing the new drug application for Crofelemer is Sept. 5, 2012, a three-month extension. The FDA did not request additional studies on the drug.

The news comes a week after the FDA requested an extension on another Salix (Nasdaq: SLXP) drug – Relistor, to treat constipation in patients on pain medication.

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