US FDA revises vancomycin generic bioequivalence standards

The US FDAhas proposed new bioequivalence guidelines for vancomycin oral capsules that require an in vivo study with clinical endpoints only when a generic's inactive ingredients are not substantially similar to those of the reference listed drug, Viropharma's Vancocin.

The draft guidelines drew criticism and a lawsuit from Viropharma, which petitioned the agency more than two years ago to...