Months after the launch of its Commissioner’s National Priority Voucher (CNPV) program, the U.S. Food and Drug Administration (FDA) has granted its first approval under this initiative to Augmentin XR, an antibiotic produced by USAntibiotics.
The FDA announced that the review for Augmentin XR was completed in two months. The agency stated that the application "demonstrated clear alignment with . . . national health priorities by strengthening the U.S. drug supply chain through enhanced domestic manufacturing." According to the FDA, this approval is expected to help address antibiotic shortages in the United States.
Augmentin XR is an extended-release combination of amoxicillin and clavulanate potassium, both previously approved for infectious diseases. The drug was originally developed by GSK and first approved in 2002; USAntibiotics is now its only domestic manufacturer.
USAntibiotics president Patrick Cashman commented on the significance of this development: “Domestic pharmaceutical manufacturing capacity is a national security imperative, not a luxury.”
The recent review focused on production aspects, involving experts in areas such as drug substance, product manufacturing, facilities, and biopharmaceutics. The CNPV program facilitated integrated quality assessment and improved communication between the FDA and pharmaceutical sponsors during the process.
Launched in June, the CNPV program aims to speed up reviews for drugs aligned with certain national priorities, reducing typical timelines from 10–12 months down to 1–2 months. In October, nine vouchers were awarded under this program—including one to Augmentin XR for promoting domestic production of essential antibiotics. Other recipients included Regeneron’s gene therapy DB-OTO for congenital deafness and Sanofi’s diabetes treatment Tzield. A second round of vouchers followed a month later, recognizing products such as Novo Nordisk’s Wegovy and Eli Lilly’s orforglipron.
A correction issued on December 10 clarified that USAntibiotics—not GSK—received both the voucher and approval; GSK had originally made Augmentin XR before it went off patent in 2011.
