Posted by Michael Wonder on 10 Dec 2025
First approval in Commissioner's National Priority Voucher Pilot Program strengthens domestic antibiotic manufacturing capacity
9 December 2025 - The US FDA today approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher pilot program, marking the first approval achieved through this review pathway.
The approval was completed in just two months, representing a major reduction of the review timeline for this type of application.
