• 31 approvals for affected products have been withdrawn to date, and there are no drug approval withdrawals currently pending. After an approval is voluntarily withdrawn, those product(s) can no longer be marketed or sold in the United States.
*The level of summary detail provided in this update for pending supplemental applications is limited by the need to protect confidential business information (CBI). To avoid revealing CBI, either directly or indirectly, the level of summary detail provided for future updates regarding GFI #213-related pending actions may change as this voluntary initiative progresses and the pool of affected applications gets smaller. Given the small number of pending changes and completed changes at this time, FDA cannot provide more information about the type of drug being affected (e.g., application type, species, indication, etc.) in this update without revealing protected information.
FDA will continue to work with the animal pharmaceutical industry, animal producers and the veterinary community to address antimicrobial resistance and preserve the effectiveness of antimicrobials of human health importance.