The U.S. Food and Drug Administration has granted approval for Augmentin XR under its Commissioner’s National Priority Voucher (CNPV) pilot program, marking the first-ever drug approval through this expedited pathway. The review was completed in just two months, a major acceleration compared with traditional timelines. 

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

The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals by bolstering domestic production capacity. It also addresses chronic antibiotic shortages that have plagued U.S. healthcare over the past 20 years. 

Global supply chain vulnerabilities for active pharmaceutical ingredients, coupled with sudden spikes in clinical demand, have fueled shortages of essential medicines like amoxicillin. Between amoxicillin and Augmentin XR, the FDA has documented nine shortage reports, underscoring the urgent need for reliable domestic production to protect public health. 

The accelerated review was conducted by a multidisciplinary FDA team, including experts in drug substance, manufacturing, and biopharmaceutics. Close coordination with the sponsor allowed the application to meet the CNPV’s two-month review target, a process that typically takes significantly longer. 

Augmentin XR is an oral antibacterial combination of amoxicillin and the β-lactamase inhibitor clavulanate, indicated for community-acquired pneumonia and acute bacterial sinusitis in adults and children.