FDA Approves Return of Augmentin XR to U.S. Market After 14-Year Hiatus

The U.S. Food and Drug Administration (FDA) made history this week by approving the return of USAntibiotics’ Augmentin XR (amoxicillin-clavulanate potassium) to U.S. market under the Commissioner’s National Priority Voucher (CNPV) pilot program. This landmark decision marks the first drug approval achieved through the CNPV expedited pathway, completed in just two months—a major reduction from the typical 10 to 12-month standard review timeline. The approval was announced by the FDA on December 9, 2025.

The primary goal of the CNPV program is to expedite applications that align with critical national health priorities, including promoting domestic manufacturing and addressing large unmet medical needs. USAntibiotics, the country’s only domestic manufacturer of amoxicillin and amoxicillin clavulanate, demonstrated clear alignment by enhancing domestic manufacturing capacity at its U.S. facility in Bristol, Tennessee.

This approval returns a critical extended-release antibiotic to U.S. pharmacy shelves for the first time in 14 years, as Augmentin XR had been unavailable since 2011 when the previous foreign owner ceased production. The drug is indicated for treating community-acquired pneumonia and acute bacterial sinusitis in both adult and pediatric patients.

The re-introduction of Augmentin XR is a significant tool in addressing persistent antibiotic shortages that have affected the U.S. healthcare system for two decades. FDA Commissioner Marty Makary emphasized the importance of this shift, stating, “We’re entering a new era of manufacturing here at home,” to regain control of supply chains for key medicines.

A key advantage of Augmentin XR is its simpler, twice-daily dosing regimen, unlike conventional formulations that require three daily doses. USAntibiotics President Patrick Cashman highlighted that this improved adherence can help reduce treatment failure and combat antimicrobial resistance. Cashman referred to the approval as a "homecoming for a life-saving medicine that American patients lost access to more than a decade ago".

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🔖 Sources

First Approval in Commissioner's National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity

 FDA Approves USAntibiotics’ Augmentin XR in Historic First for Expedited Review Program

FDA awards 1st national priority nod to USAntibiotics' Augmentin XR

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Keywords: Return of Augmentin XR to U.S. Market

Return of Augmentin XR to U.S. Market

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