The Food and Drug Administration (FDA) yesterday approved a US-manufactured version of the oral antibiotic Augmentin XR (amoxicillin-clavulanate potassium) under a pilot program that aims to fast-track the review process for drugs.
The approval is the first under the Commissioner’s National Priority Voucher (CNPV) program, which was launched in June. FDA officials said the approval was completed in just two months. FDA review of drug applications typically takes 10 to 12 months.
Augmentin XR is an extended-release formulation of Augmentin that was originally developed by GSK and approved by the FDA in 2002. The drug is used to treat community-acquired bacterial pneumonia and acute bacterial sinusitis in adults and children. As recently as 2024, it was on the FDA discontinued drug products list, according to the website Biopharma Dive.
Boosting US drug manufacturing
The FDA said the approval, granted to USAntibiotics of Bristol, Tennessee, will both boost US drug manufacturing and address US antibiotic shortages driven by global supply chain vulnerabilities. Augmentin XR has experienced two shortages in recent years, the agency said. The plant in Bristol where the drug will be manufactured was originally owned by GSK before it sold its US penicillin business in 2010.
USAntibiotics was one of nine companies tabbed by the FDA for the CNPV program in October. Six additional companies have since received vouchers. The pilot program is focused on products that address large unmet medical needs, bring innovative therapies to Americans, promote domestic manufacturing, and increase drug affordability.
“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,” FDA Commissioner Marty Makary, MD, MPH, said in an agency press release. “This first drug approval under the CNPV pilot program will strengthen domestic manufacturing and increase our national security.”
In a statement released after the receiving the voucher, USAntibiotics president Patrick Cashman said domestic pharmaceutical manufacturing is a “national security imperative, not a luxury.”
“We are enormously grateful that the FDA and policymakers in Washington are prioritizing domestic manufacturing of generic critical medicines.”
