On Dec. 11, 2025, USAntibiotics, the country’s only domestic manufacturer of amoxicillin (Amoxil®) and amoxicillin clavulanate (Augmentin®), announced that the U.S. Food and Drug Administration (FDA) has approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner’s National Priority Voucher (CNPV) pilot program.

The FDA’s re-approval marks the first drug approved through the CNPV expedited pathway and returns a critical extended-release antibiotic formulation to American patients for the first time in 14 years. Augmentin XR has been unavailable in the United States since August 2011, when USAntibiotics’ previous foreign owner ceased production. The FDA confirmed in October 2024 that the drug was not withdrawn for safety or effectiveness concerns.

Augmentin XR is an extended-release oral antibacterial combination of amoxicillin and clavulanate potassium indicated for the treatment of community-acquired pneumonia and acute bacterial sinusitis in adult and pediatric patients. Unlike conventional antibiotic formulations that require three daily doses, Augmentin XR is taken twice daily, a significant advantage for patient adherence.

Clinical research has shown that some patients struggle to complete antibiotic courses requiring three or more daily doses.

This approval addresses persistent antibiotic shortages that have plagued the U.S. healthcare system for two decades by increasing the number and availability of proven antibiotic treatments available to healthcare providers.