The FDA has approved USAntibiotics' Augmentin XR through the Commissioner’s National Priority Voucher (CNPV) pilot program, making the antibiotic the first drug to receive approval using this review pathway.
Augmentin XR is an oral antibacterial combination of amoxicillin (a semisynthetic antibiotic) and clavulanate (a β-lactamase inhibitor). The medication is prescribed for community-acquired pneumonia and acute bacterial sinusitis.
The drug received approval after just two months. Announced in June, the CNPV program aims to shorten drug review times for companies "aligned with U.S. national priorities.” The new voucher may be redeemed by drug developers to participate in a priority program that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission.
There have been shortages of antibiotics in the U.S. over the past two decades due to both issues with global supply chains that have influenced availability of active pharmaceutical ingredients and unexpected spikes in demand. This has led to delays in patients receiving treatment and the increased use of broader-spectrum antibiotics due to less availability of first-line therapies.