Cholestin Decision Threat To "Pioneer" Drug Exclusivity Cited In FDA Appeal

The Salt Lake City federal court decision that Pharmanex' red yeast rice product Cholestin can be marketed as a dietary supplement violates "two broad purposes" of the FD&C Act - Rx drug exclusivity and generic drug availability, FDA maintains in a brief filed with the Utah federal appeals court July 20. Pharmanex has until the end of August to respond to the brief.