BioPharma Dive December 10, 2025
The agency gave the green light to a U.S. company manufacturing Augmentin XR, an antibiotic first approved more than two decades ago.
Dive Brief:
- The Food and Drug Administration has cleared the first medicine under its new National Priority Voucher program, approving a U.S.-manufactured version of a decades-old antibiotic.
- GSK originally developed the drug, Augmentin XR, and won FDA approval for it in 2002. The British company then struck a deal in 2010 to sell its U.S. penicillin business, including its Augmentin franchise, to the generic drugmaker Dr. Reddy’s Laboratories. A Bristol, Tennessee, plant that was part of that deal is now operated by USAntibiotics, which won the priority voucher.
- FDA Commissioner Martin Makary trumpeted the approval as a...
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