CNPV
December 9, 2025
USAntibiotics receives the first approval under the Commissioner's National Priority Voucher program for Augmentin XR
The U.S. Food and Drug Administration today approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher (CNPV) pilot program, marking the first approval achieved through this review pathway.
The approval was completed in two months, though Augmentin XR was already approved by the FDA many ago under NDA 050785 before later moving to discontinued marketing status. This approval reinstates it marketing status.
