FDA’s CNPV Pilot Gives First Approval to Antibiotic for Pneumonia and Sinusitis

An amoxicillin-clavulanate potassium antibiotic made by USAntibiotics has become the first drug to be approved via FDA’s Commissioner’s National Priority Review (CNPV) pilot program, with FDA saying the approval was completed in just two months (1). Antibiotics, particularly amoxicillin and Augmentin XR, the brand name of the USAntibiotics drug, have been subject to increasing, documented shortages in the past two decades, according to FDA.

“Over the past few decades, America lost control of supply chains for key medicines we depend on,” FDA Commissioner Marty Makary, MD, MPH, said in a press release (1). “That chapter is…