FDA approved Augmentin XR (amoxicillin-clavulanate potassium) for the treatment of community-acquired pneumonia and acute bacterial sinusitis in both adult and pediatric patients, marking the first drug to be approved in the Commissioner’s National Priority Voucher Pilot Program (CNPV).

Augmentin XR is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor clavulanate and was one of the original nine medications to be named in the CNPV.

The FDA introduced CNPV back in June of this year, designing it to reduce review periods for certain drug applications aligning with critical U.S. health and security objectives. As part of this program, qualifying sponsors are granted a voucher enabling FDA to complete its review in one to two months following final submission compared to the traditional 10–12-month review window.

"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,” said FDA commissioner Marty Makary, M.D., M.P.H. "This first drug approval under the CNPV pilot program will strengthen domestic manufacturing and increase our national security."

Augmentin XR’s accelerated review process under the CNPV

According to the agency, Augmentin XR’s application demonstrated clear alignment with the CNPV program's national health priorities and also helped provide strength in the U.S. drug supply chain, enhancing domestic manufacturing capacity at a select U.S. facility.¹

Augmentin XR’s approval is also expected to help address the concern of antibiotic shortages in the U.S. healthcare system that has lingered over the past two decades.¹

The review of Augmentin XR was conducted by a multidisciplinary team comprised of experts from several fields of study, including drug substance, drug product, manufacturing, facilities, and biopharmaceutics.¹ Both FDA and GSK’s, the medication’s sponsor, integrated quality assessment and enhanced communications throughout the process enabled the accelerated timeline from application receipt to approval within the target two-month CNPV review window.¹

Antibiotic shortages a factor in Augmentin XR’s approval

According to FDA, essential medicines such as amoxicillin and Augmentin XR have experienced documented shortages, including seven shortage reports for amoxicillin and two for Augmentin XR.These shortages indicated a critical need for the agency to stabilize domestic manufacturing capabilities in order to protect public health.¹

The increase in antibiotic shortages over the last two decades has been primarily driven by global supply chain vulnerabilities for active pharmaceutical ingredients and also unexpected spikes in clinical demand, resulting in significant clinical consequences, such as treatment delays and an increased reliance on broader-spectrum antibiotics.¹

What other medications are in the CNPV program?

Back in November, the agency added six new medications to the program, extending the total to 15 medications that address critical public health and national security priorities.

The most recent additions to the program include:

• Hernexeos (zongertinib) for HER2 lung cancer
• Sirturo (bedaquiline) for drug-resistant tuberculosis in young children
• Jemperli (dostarlimab) for rectal cancer
• Casgevy for sickle cell disease
• Orforglipron for obesity and related health conditions
• Wegovy for obesity and related health conditions

These medications join the first nine drugs that were originally announced for CNPV:

• Pergoveris for infertility
• Teplizumab for Type I diabetes
• Cytisinicline for nicotine vaping addiction
• DB-OTO for deafness
• Cenegermin-bkbj for blindness
• RMC-6236 for pancreatic cancer
• Bitopertin for porphyria
• Ketamine for domestic manufacturing of a critical drug for general anesthesia
• Augmentin XR for domestic manufacturing of a common antibiotic

Sources

1. First Approval in Commissioner's National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity U.S. Food and Drug Administration December 9, 2025 https://www.fda.gov/news-events/press-announcements/first-approval-commissioners-national-priority-voucher-pilot-program-strengthens-domestic-antibiotic