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.

Source: Press Release

Track every
FDA Priority Review Voucher Program.

Stay updated
Thank you!
Oops! Something went wrong while submitting your email.

This webpage has been compiled from manually reviewing thousands of documents from the U.S. Securities and Exchange Commission (SEC), U.S. Food and Drug Administrations (FDA), Federal Register, press releases and financial records. The information on this page has been compiled from publicly available sources only and does not include any undisclosed PRV issuance's, transactions or redemptions.

Stay in the loop

News, analysis, and insights from the world of Priority Review Vouchers.

Thank you!
Oops! Something went wrong while submitting your email.