FDA action on Salix' crofelemer delayed until 2013

There was disappointing news for Salix Pharmaceuticals (Nasdaq: SLXP) with the Food and Drug Administration advising the company that its New Drug Application for crofelemer for the proposed indication of symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy, is still under review and that a final action will not be taken by the scheduled Prescription Drug User Fee Act (PDUFA) goal date of September 5, 2012.

The FDA previously delayed its decision by three months in April, but did not ask for additional clinical studies to be conducted. Analysts estimate crofelemer, a proprietary proanthocyanidin, if approved, may add about $22 million in sales next year and $33 million in 2014, according to the average of seven estimates compiled by Bloomberg.