Written By: Pharmacally Medical News Desk
The U.S. Food and Drug Administration (FDA) has approved Augmentin XR (amoxicillin-clavulanate potassium), an oral antibiotic, under the Commissioner’s National Priority Voucher (CNPV) pilot program, achieving the first approval through this expedited pathway in just two months.
This milestone addresses U.S. antibiotic shortages by enhancing domestic manufacturing at a U.S. facility, aligning with national health priorities like supply chain resiliency.
FDA Commissioner Marty Makary, M.D., M.P.H., emphasized that the U.S. has reclaimed control over vital medicine supply chains after decades of vulnerability, ushering in domestic manufacturing resurgence, with this approval bolstering national security through enhanced production capacity.
Antibiotic Shortages and Domestic Needs
Essential medicines like amoxicillin and Augmentin XR have faced documented shortages, including seven reports for amoxicillin and two for Augmentin XR, underscoring the urgent requirement for reliable U.S.-based production to safeguard public health.
These shortages highlight vulnerabilities in global supply chains, particularly for critical antibiotics needed to fight bacterial infections amid rising resistance. The Augmentin XR approval directly counters this by prioritizing stable domestic capacity.
CNPV Pilot Program Details
Launched in June 2025 under FDA Commissioner Marty Makary, the CNPV program cuts standard 10-12 month review timelines to 1-2 months via multidisciplinary “tumor board-style” evaluations, enhanced sponsor communication, and rolling reviews.
Priorities include onshoring manufacturing, tackling public health crises like antibiotic shortages, innovative cures, unmet needs, and affordability while upholding safety and efficacy standards; hence this voucher go to aligned applications.
CNPV Alignment and Supply Chain Boost
The Augmentin XR application perfectly matched CNPV goals by boosting U.S. drug supplies through more production at a USAntibiotics plant at Bristol, Tennessee in USA. This step guarantees steady access to key antibiotics, cuts risks from relying on other countries, and helps respond quickly to health emergencies. FDA’s check confirmed it fit well, speeding up approval without lowering safety checks.
Augmentin XR Overview
Augmentin XR contains semisynthetic antibiotic amoxicillin with β-lactamase inhibitor clavulanate potassium in an extended-release tablet for oral use. It treats community-acquired pneumonia and acute bacterial sinusitis in adults and pediatric patients caused by penicillin-resistant bacteria. USAntibiotics now produces this previously approved drug in the U.S. to ensure steady supplies of this essential medicine.
Technical Aspects of Approval
FDA conducted a multidisciplinary review involving experts in drug substance, product, manufacturing, facilities, and biopharmaceutics, using integrated quality assessments, enhanced sponsor communication, and rolling reviews to complete approval in two months.
GlaxoSmithKline (GSK) originally marketed Augmentin XR in the USA since 2002. Now USAntibiotics secured a CNPV voucher in October 2025 and gained approval for domestic production and marketing on 09 December 2025.
USAntibiotics manufactures Augmentin XR at its 394,000-square-foot FDA-approved facility in Bristol, Tennessee, the only U.S. site for amoxicillin and Augmentin oral doses. The company now markets and distributes this essential antibiotic nationwide.
References
First Approval in Commissioner’s National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity, 09 December 2025, https://www.fda.gov/news-events/press-announcements/first-approval-commissioners-national-priority-voucher-pilot-program-strengthens-domestic-antibiotic
USAntibiotics Awarded FDA National Priority Voucher for Domestic Manufacturing of Critical Antibiotic, USAntibiotics.com, 22 October 2025, https://usantibiotics.com/2025/10/22/usantibiotics-awarded-fda-national-priority-voucher-for-domestic-manufacturing-of-critical-antibiotic/
Commissioner’s National Priority Voucher (CNPV) Pilot Program, 06 November 2025, US FDA, https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program