Group Asks FDA to Get Public Input on Bioequivalence Standards

Viropharma has received support from the Washington Legal Foundation (WLF) in its lawsuit seeking to prevent the FDA from approving a generic version of the company’s gastrointestinal antibiotic Vancocin without requiring in vivo testing in humans. In an amicus brief filed Jan. 28 with the U.S. District Court for the District of Columbia, WLF argues that the FDA has changed the standards it uses to determine that a generic drug is equivalent to its brand counterpart without notifying or seeking comment from the public.
Washington Drug Letter