BRISTOL, Tenn. — USAntibiotics, the nation’s only domestic producer of amoxicillin (Amoxil) and amoxicillin clavulanate (Augmentin), announced that the U.S. Food and Drug Administration has awarded its Augmentin XR product the inaugural Commissioner’s National Priority Voucher (CNPV). The new program provides expedited regulatory review for critical medicines manufactured in the United States, with the potential to shorten FDA review timelines from the standard 10–12 months to as little as one to two months.
“This voucher validates what we’ve known since reopening our Bristol, Tennessee facility in 2021: domestic pharmaceutical manufacturing capacity is a national security imperative, not a luxury,” said Patrick Cashman, President of USAntibiotics. “If our doors close, it would take half a decade and hundreds of millions of dollars to rebuild this capability from scratch. That’s five years in which America would be completely reliant on adversarial nations for the most prescribed antibiotic in the country. We are enormously grateful that the FDA and policymakers in Washington are prioritizing domestic manufacturing of generic critical medicines.”
Augmentin XR, an extended-release formulation of amoxicillin and clavulanate potassium, is approved by the FDA for the treatment of community-acquired pneumonia and acute bacterial sinusitis caused by penicillin-resistant bacteria. The CNPV designation does not guarantee product approval but underscores the agency’s focus on bolstering the U.S. supply chain for essential medications.
USAntibiotics operates a 394,000-square-foot manufacturing facility in Bristol, Tennessee, capable of producing enough amoxicillin products to meet the entire U.S. demand. The recognition comes as U.S. health officials continue to highlight the need for greater domestic production of antibiotics and other critical drugs amid ongoing supply chain vulnerabilities.
In a recent FDA Direct podcast, Commissioner Makary commended the company’s work, saying, “Thank you for making it in the United States of America.”
