US FDA approves first drug under new fast-track review program
The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program designed to shorten review time for a drug application.
The approval for the antibiotic Augmentin XR was completed in two months, the agency said, compared with the typical timeline of about 10-12 months.
Augmentin XR, an oral antibacterial combination of amoxicillin and clavulanate, is used to treat pneumonia and bacterial sinus infections in adults and children.
Launched in June, the Commissioner’s National Priority Voucher program aims to speed FDA decisions on drugs addressing critical public health or national security needs, and the agency has issued 15 vouchers so far.
“This first drug approval under the CNPV pilot program will strengthen domestic manufacturing and increase our national security,” FDA Commissioner Marty Makary said.
The Augmentin XR application aligns with the CNPV program’s national health priorities by bolstering the U.S. drug supply chain through expanded domestic manufacturing and addressing antibiotic shortages, the FDA said.
