Wedoany.com Report-Dec.10, The United States Food and Drug Administration (FDA) announced on Tuesday the approval of Augmentin XR, the first medicine to complete review under its new Commissioner's National Priority Voucher (CNPV) fast-track program. The decision was reached in just two months, significantly shorter than the standard 10- to 12-month review period.

Augmentin XR is an extended-release oral antibiotic combining amoxicillin and clavulanate. It is indicated for the treatment of community-acquired pneumonia and acute bacterial sinusitis in adults and pediatric patients.

Launched in June, the CNPV pilot program is designed to accelerate FDA reviews for medicines that address important public health requirements or enhance national resilience. To date, the agency has awarded 15 priority vouchers.

"This first drug approval under the CNPV pilot program will strengthen domestic manufacturing and increase our national security," said FDA Commissioner Marty Makary.

The Augmentin XR application qualified for priority review because it supports increased domestic production capacity and helps address ongoing shortages of critical antibiotics. Expanded U.S.-based manufacturing of the product is expected to improve supply reliability for these widely used treatments.

The successful two-month review demonstrates the effectiveness of the CNPV framework in delivering faster access to essential medicines while maintaining rigorous safety and efficacy standards. The program enables the FDA to allocate additional resources to applications that align with defined national health and supply-chain priorities, benefiting patients who require timely treatment for serious bacterial infections.