The Food and Drug Administration (FDA) yesterday approved a US-manufactured version of the oral antibiotic Augmentin XR (amoxicillin-clavulanate potassium) under a pilot program that aims to fast-track the review process for drugs.

The approval is the first under the Commissioner’s National Priority Voucher (CNPV) program, which was launched in June. FDA officials said the approval was completed in just two months. FDA review of drug applications typically takes 10 to 12 months.

Augmentin XR is an extended-release formulation of Augmentin that was originally developed by GSK and approved by the FDA in 2002. The drug is used to treat community-acquired bacterial pneumonia and acute bacterial sinusitis in adults and children. As recently as 2024, it was on the FDA discontinued drug products list, according to the website Biopharma Dive.

Boosting US drug manufacturing 

The FDA said the approval, granted to USAntibiotics of Bristol, Tennessee, will both boost US drug manufacturing and address US antibiotic shortages driven by global supply chain vulnerabilities. Augmentin XR has experienced two shortages in recent years, the agency said. The plant in Bristol where the drug will be manufactured was originally owned by GSK before it sold its US penicillin business in 2010.

USAntibiotics was one of nine companies tabbed by the FDA for the CNPV program in October. Six additional companies have since received vouchers. The pilot program is focused on products that address large unmet medical needs, bring innovative therapies to Americans, promote domestic manufacturing, and increase drug affordability. 

"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 an agency press release. "This first drug approval under the CNPV pilot program will strengthen domestic manufacturing and increase our national security."

In a statement released after the receiving the voucher, USAntibiotics president Patrick Cashman said domestic pharmaceutical manufacturing is a “national security imperative, not a luxury.”

“We are enormously grateful that the FDA and policymakers in Washington are prioritizing domestic manufacturing of generic critical medicines.”

New outbreaks of highly pathogenic avian influenza (HPAI) have been reported in five states, according to the latest update from the US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS).

The hardest hit state is Indiana, where outbreaks affecting more than 15,000 birds have been reported in three commercial duck meat facilities in Elkhart, LaGrange, and Noble counties. An additional 19,400 birds have been affected in an outbreak at a poultry facility in LaGrange. The three countries border one another and are in the northeastern part of the state.

APHIS also reported an outbreak at a commercial poultry in North Dakota, and outbreaks in backyard flocks in Washington, Wyoming, and West Virginia.

HPAI detections are higher in the fall and spring, as wild birds spread the virus during migration. Over the past 30 days, 108 flocks (44 commercial and 64 backyard) have been hit by HPAI outbreaks, with 1.16 million birds affected. 

Dead vultures in Ohio

In other avian flu news, health officials in Ohio say preliminary lab results for two dead vultures found in Pierce Township indicate the birds died from HPAI. The two vultures were among the more than 70 that were found dead on the athletic fields of a local school near Cincinnati on December 1.

A news release from Clermont County Public Health says it will take 10 days to confirm the presumptive HPAI diagnosis as the cause of death.