Program provides for expedited regulatory review, supporting expanded domestic production of critical, life-saving medication

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) selected its Augmentin XR product for the agency's inaugural Commissioner's National Priority Voucher (CNPV) Program. The new voucher promises a review decision within one to two months following submission of a complete application, collapsing the typical 10 to 12-month FDA timeline.

"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, 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 is an FDA-approved extended-release combination of amoxicillin and clavulanate potassium. This product is indicated for treatment of community-acquired pneumonia and acute bacterial sinusitis caused by bacteria that resist penicillin, as described in the approved product labeling. Full prescribing information is available here.

The CNPV recognition, which does not ensure approval, comes at a moment when America's pharmaceutical supply chain remains precariously dependent on foreign manufacturers for critical medicines. USAntibiotics' world-class, 394,000-square-foot production facility in Bristol, Tennessee, has the capacity to produce enough amoxicillin products to meet 100% of the nation's demand for these essential medications. In the agency's FDA Direct podcast, Commissioner Makary said Friday of USAntibiotics' production of amoxicillin and Augmentin: "Thank you for making it in the United States of America."

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.

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