The FDA has approved Augmentin XR under the Commissioner’s National Priority Voucher (CNPV) pilot program.
Augmentin XR, or amoxicillin-clavulanate potassium, marks the first approval through this new review pathway, which HPN previously reported on. The approval came through in two months. The pilot program is meant to “strengthen domestic manufacturing and increase [U.S.] national security.”
The approval of Augmentin XR will “help address antibiotic shortages in the U.S. that have plagued the healthcare system over the past two decades.” Those shortages have been “primarily driven by global supply chain vulnerabilities for active pharmaceutical ingredients and unexpected spikes in clinical demand,” according to the FDA. The shortages can result in treatment delays and increased reliance on broader-spectrum antibiotics.
There have been seven documented shortage reports for amoxicillin and two for Augmentin XR. Augmentin XR is an “oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor clavulanate. The medication is indicated for the treatment of community-acquired pneumonia and acute bacterial sinusitis in both adult and pediatric patients.”
