Cholestin Decision Threat To "Pioneer" Drug Exclusivity Cited In FDA Appeal
This article was originally published in The Tan Sheet
Executive Summary
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.
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Cold, allergy and immune system claims were the most commonly cited statements in FDA "courtesy" letters issued to dietary supplement companies in 1999, although the number of letters addressing these conditions declined from 1998.
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