The FDA has approved Augmentin XR, an oral antibacterial, under its Commissioner’s National Priority Voucher pilot program, marking the first approval granted through the expedited review pathway.
The approval met the program’s target two-month timeline and fulfilled criteria by supporting domestic pharmaceutical manufacturing and addressing U.S. antibiotic shortages, according to a Dec. 9 news release.
The voucher program, which launched in June, is designed to speed reviews for therapies aligned with public health priorities, affordability or supply chain resilience. The FDA named its first nine voucher recipients in October and added six more in November, including obesity drugs orforglipron and Wegovy, and gene therapies for sickle cell disease and congenital deafness.
Augmentin XR, a combination of amoxicillin and clavulanate, will be manufactured at a U.S.-based facility using a digitally integrated system to bolster supply chain reliability. The drug is indicated for community-acquired pneumonia and acute bacterial sinusitis.
The FDA said sponsors with a voucher who submit a complete application may receive a decision within months. The agency has granted 15 vouchers to date.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.