The Commissioner’s National Priority Voucher program was launched in June to shorten review times for companies that align with various national priorities, such as improving domestic drug production and supply.
Months after kicking off its Commissioner’s National Priority Voucher program, the FDA issued its first approval under the scheme, to the antibiotic Augmentin XR, manufactured by the generics company USAntibiotics.
The review was completed in “just two months,” the regulator said in its news release, adding that the drug’s application “demonstrated clear alignment with . . . national health priorities by strengthening the U.S. drug supply chain through enhanced domestic manufacturing.” Augmentin XR’s approval, the FDA continued, will in turn help the U.S. address antibiotic shortages.
It is unclear what new regulatory status the approval confers on Augmentin XR. BioSpace has reached out to the Department of Health and Human Services for clarity on the matter.
Augmentin XR is an extended release formulation of a combination of the synthetic antibiotic amoxicillin and the β-lactamase inhibitor clavulanate potassium. Both have long been approved by the FDA for use against infectious diseases. Augmentin XR, developed by GSK, was first approved in the U.S. in 2002. Today, its sole domestic manufacturer is USAntibiotics.
“Domestic pharmaceutical manufacturing capacity is a national security imperative, not a luxury,” USAntibiotics president Patrick Cashman said in a statement following Tuesday’s approval.
The recent review of Augmentin XR under the commissioner’s priority voucher program appeared to be centered on the drug’s production, as it was carried out by “experts in drug substance, drug product, manufacturing, facilities, and biopharmaceutics,” according to the Tuesday release.
The priority program, the FDA added, allowed for “integrated quality assessment and enhanced communication” between the agency and the pharmaceutical sponsor, making for a smoother review.
The FDA launched the Commissioner’s National Priority Voucher (CNPV) program in June, aiming to expedite drug reviews for companies that abide by certain national priorities, shaving the usual review time from 10–12 months to 1–2 months.
The agency awarded the first nine tickets in October, one of which went to Augmentin XR, specifically for its role in promoting the domestic manufacturing of common but highly needed antibiotics. Other awardees in this first batch included Regeneron’s congenital deafness gene therapy DB-OTO and Sanofi’s type 1 diabetes drug Tzield.
The second batch of vouchers was given a month later and included awards to Novo Nordisk’s obesity blockbuster Wegovy and Eli Lilly’s investigational weight-loss pill orforglipron.
Correction, Dec. 10: This article has been updated to clarify that USAntibiotics, not GSK, was awarded the voucher and received the approval. GSK was the original maker of Augmentin XR before the drug went off patent in 2011. BioSpace regrets the error.
