Antibiotic Is First Approval in FDA National Priority Scheme

FDA approves first drug in National Priority Voucher program

The agency gave the green light to a U.S. company manufacturing Augmentin XR, an antibiotic first approved more than two decades ago.

Antibiotic is first approval in FDA national priority scheme

FDA approves its first 'national priority' drug – a version of the widely used antibiotic Augmentin XR – in double-quick time.

FDA approves first drug in National Priority Voucher program – RamaOnHealthcare

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 Grants First Approval Under Priority Voucher Program, Fast-Tracking Antibiotic to Strengthen US Drug Supply Chain

The federal agency approved Augmentin XR in just 2 months through the new CNPV pilot program, marking a potential step toward rebuilding domestic antibiotic manufacturing and addressing drug shortages.