US FDA delays Salix' Crofelemer approval

US drugmaker Salix Pharmaceuticals (Nasdaq: SLXP) revealed yesterday that the Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) goal date for the Agency’s Priority Review of the New Drug Application for Crofelemer 125mg tablets for the proposed indication for the control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy (ART).

The FDA has notified Salix that it requires additional time for a full review of the submission and has extended the June 5, 2012 goal date by three months. The extended user fee goal date is now September 5, 2012. The FDA did not request additional studies, the company said.

Salix filed the NDA for Crofelemer last year (The Pharma Letter December 15, 2011), just as there were more revelations on its arguments with the drug’s originator, California-based Napo Pharmaceuticals, which claimed that Salix had failed to develop Crofelemer and other alleged breaches of the parties’ collaboration agreement.