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.”

The Pan American Health Association (PAHO) said the Americas region needs to significantly increase pertussis vaccine coverage and uptake, as cases of whooping cough are surging in a number of countries. 

In 2022, the region reported 3,284 cases, and by last year that number had jumped to 66,184 cases. 2025 is expected to top that.

“Whooping cough is a vaccine-preventable disease, but its resurgence highlights gaps in immunization and epidemiological surveillance,” said Dr. Daniel Salas, executive manager of PAHO’s special program on integrated immunization in a PAHO press release. “It is urgent that countries ensure high and consistent vaccination coverage, especially among children under five, to protect the most vulnerable and prevent outbreaks.”

US has 25,000 cases so far this year

PAHO said pertussis vaccination coverage dropped during the COVID-19 pandemic, with 87% coverage in the region for the first dose (DTP1) and 81% for the third dose (DTP3). Last year coverage rebounded somewhat to 89% and 87%, respectively, but there are significant disparities country-to-country. 

It is urgent that countries ensure high and consistent vaccination coverage, especially among children under five.

In an epidemiologic report, PAHO said the United States has seen by far the most whooping cough cases so far in 2025, with 25,057 confirmed and probable cases, including 13 deaths. Washington state, California, and Florida had the highest case counts. Peru has the second most infections, 3,200, including 49 deaths.

In all countries, whooping cough deaths were primarily seen in infants under 1 year of age.