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US FDA revises vancomycin generic bioequivalence standards

 
• By Sue Sutter

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 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...

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