The FDA may have changed its bioequivalence testing standards for generic firms seeking to market versions of the antibiotic Vancocin, according the drug's distributor.
ViroPharma filed a "petition for stay of action" with the FDA March 17, objecting to the agency's apparent policy change on Vancocin (vancomycin HCl), which is used to fight bacterial rather than viral infections.
The company said it was "informed" that the FDA's Office of Generic Drugs (OGD) may allow generic drugmakers to request a waiver of in vivo bioequivalence testing for Vancocin if dissolution testing shows the generic product to rapidly dissolve in certain specified conditions.
ViroPharma said it vigorously opposes any approach that does not require "rigorous scientific methods to demonstrate a rate and extent of drug release to the site of action consistent with good medicine and science." The company expects to make additional filings with the FDA in support of its opposition.