Overview
- The FDA approved Augmentin XR under its Commissioner's National Priority Voucher pilot after an expedited review of roughly two months.
- Regulators selected the application in part because manufacturing will occur at a U.S.-based facility to reinforce domestic capacity for essential medicines.
- The agency said the decision is expected to help ease persistent antibiotic shortages that have disrupted care and encouraged broader-spectrum prescribing.
- The CNPV pilot prioritizes applications aligned with national health goals such as manufacturing resilience, large unmet needs, innovation, and affordability, using a multidisciplinary review team and rapid sponsor communications.
- Augmentin XR (amoxicillin–clavulanate) is indicated for community-acquired pneumonia and acute bacterial sinusitis and was originally approved in the U.S. in 1984, with this action setting a precedent for other voucher awardees.