FDA Grants First Approval Under Priority Voucher Program, Fast-Tracking Antibiotic to Strengthen US Drug Supply Chain

The FDA has approved Augmentin XR (amoxicillin-clavulanate potassium) under the FDA Commissioner's National Priority Voucher (CNPV) pilot program—the first drug approval achieved through this new expedited review pathway.¹ The agency called the decision, completed within a 2-month window, a significant milestone in the federal effort to restore and secure domestic pharmaceutical manufacturing.

“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 a statement.¹ “This first drug approval under the CNPV pilot program will strengthen domestic manufacturing and increase our national security.”

The Augmentin XR application was selected for the program based on its alignment with national health priorities, particularly in efforts to reinforce the US drug supply chain. Production will take place at a US-based facility, directly supporting national initiatives to rebuild capacity for essential medicines. The approval is also expected to alleviate ongoing antibiotic shortages that have disrupted patient care for nearly two decades.

Augmentin XR, an oral antibacterial combination of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor clavulanate, is approved for treatment of community-acquired pneumonia and acute bacterial sinusitis in both adults and children. Its initial approval in the US came in 1984.²

Antibiotic shortages, including 7 documented shortages of amoxicillin and 2 of Augmentin XR, have been driven by vulnerabilities in global sourcing of active pharmaceutical ingredients and unpredictable spikes in medical demand, the agency stated. These supply gaps have forced clinicians to delay treatment or rely on broader-spectrum agents, increasing risks for complications and antimicrobial resistance.

The CNPV Review Process

To meet the CNPV program’s accelerated 2-month target, the FDA employed a multidisciplinary review structure encompassing drug substance, drug product, manufacturing, facilities, and biopharmaceutics experts^.1,3 The FDA stated that enhanced communication between the agency and the sponsor enabled rapid resolution of scientific questions and a highly coordinated quality assessment.¹

The CNPV pilot program is designed to speed approvals for applications advancing national health priorities, including innovative therapies, large unmet clinical needs, affordability, and—central to this approval—domestic manufacturing resilience. The success of Augmentin XR’s review may pave the way for broader use of the program to strengthen the nation’s pharmaceutical infrastructure.

To meet the much-shortened review timeline, CNPV submissions are evaluated by a committee led by the FDA's Office of the Chief Medical and Scientific Officer, as opposed to the standard review system. Such a submission also comes with an expectation of availability for ongoing communication "with prompt responses to FDA inquiries," per the agency. It is still at FDA's discretion to extend the review window in the instances of insufficient components, unclear data, or complex review.

To be eligible for the CNPV program, the FDA cites 5 main criteria:

1. Addressing a US public health crisis. The FDA noted that this could be the development of a universal flu vaccine that protects broadly against multiple strains and could help with pandemic prevention.
2. Delivering more innovative cures for the US population. The FDA offered the example of "a novel immunotherapy that reprograms the body's immune system to fight multiple diseases" as well as "a novel treatment for PTSD."
3. Addressing a large unmet medical need. The FDA offered a definition that includes "a disease or condition that available therapies do not adequately treat, prevent, or diagnose, including drugs to treat rare diseases or address America’s chronic disease crisis."
4. Onshoring drug development and manufacturing for US health interests and supply chain resiliency. The agency offered 2 examples: a company with new manufacturing sites that shift essential manufacturing to the United States and a clinical trial with thorough US enrollment to allow for US-centric generalizability compared with the standard of care.
5. Increasing affordability. The FDA used the example of "a company that lowers the US price of a drug or reduces other downstream medical utilization to lower overall healthcare costs."

In October 2025, the FDA announced 8 other therapies that were the first to be awarded in the new program, along with Augmentin XR.⁴ They selected DB-OTO for deafness, pergoveris for infertility, teplizumab for type 1 diabetes, bitopertin for porphyria, cytisinicline for nicotine vaping addiction, cenegermin-bkbj for blindness, RMC-6236 for pancreatic cancer, and ketamine for domestic manufacturing of a critical general anesthesia drug.

References
1. First Approval in Commissioner's National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity. FDA press release. December 9, 2025. Accessed December 9, 2025.
https://www.fda.gov/news-events/press-announcements/first-approval-commissioners-national-priority-voucher-pilot-program-strengthens-domestic-antibiotic
2. Augmentin XR: Package Insert / Prescribing Info. Drugs.com. Updated March 25, 2025. Accessed December 9, 2025. https://www.drugs.com/pro/augmentin-xr.html
3. Commissioner's National Priority Voucher (CNPV) Pilot Program. FDA. Updated November 6, 2025. Accessed December 9, 2025. https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program
4. FDA Awards First-Ever National Priority Vouchers to Nine Sponsors. FDA. October 16, 2025. Accessed December 9, 2025. https://www.fda.gov/news-events/press-announcements/fda-awards-first-ever-national-priority-vouchers-nine-sponsors