The U.S. Food and Drug Administration has approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher pilot program, marking the first approval achieved through this review pathway. The approval was completed in just two months, representing a major reduction of the review timeline for this type of application.
"Over the last few decades, America lost control of supply chains for key medicines we depend on. That chapter is over - we're entering a new era of manufacturing here at home," said FDA Commissioner Marty Makary. "This first drug approval under the CNPV pilot program will strengthen domestic manufacturing and increase our national security."
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