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

Landmark approval returns extended-release antibiotic to U.S. pharmacy shelves for the first time since 2011

BRISTOL, Tenn.--(BUSINESS WIRE)--USAntibiotics, the country's only domestic manufacturer of amoxicillin (Amoxil®) and amoxicillin clavulanate (Augmentin®), announced today 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 The FDA confirmed in October 2024 that the drug was not withdrawn for safety or effectiveness concerns.

"Today marks a homecoming for a life-saving medicine that American patients lost access to more than a decade ago," said Patrick Cashman, president, USAntibiotics. "We thank Commissioner Makary and the FDA team for demonstrating that regulatory efficiency and scientific rigor can work hand in hand. This milestone proves that domestic manufacturing of critical medicines deserves the same urgent attention and industrial policy support as semiconductors and critical minerals."

FDA Commissioner Marty Makary, M.D., M.P.H., announced the approval this week, on Tuesday, December 9, stating, "Over the last few decades, America lost control of supply chains for key medicines we depend on. That chapter is over – we're entering a new era of manufacturing here at home."

A Simpler Regimen Means Better Outcomes

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.

"Poor adherence to antibiotic regimens is a major cause of treatment failure and contributes to antimicrobial resistance," Cashman added. "The return of an extended-release formulation that patients can take twice daily, instead of three times a day, gives physicians an important tool to improve outcomes and protect the effectiveness of these critical medicines."

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.

About USAntibiotics

USAntibiotics is the only U.S. manufacturer of amoxicillin and amoxicillin clavulanate, commonly known as Amoxil® and Augmentin®. Based in Bristol, Tennessee, the company operates a world-class, 394,000-square-foot antibiotic production facility with the sole focus of making quality, life-saving antibiotics widely available for the benefit of all Americans. USAntibiotics is part of the Jackson Healthcare® family of companies. For more information, visit www.us-antibiotics.com.