FDA Requests Extension to Review Salix Pharmaceuticals, Ltd. Drug
Published: May 01, 2012
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.