December 10, 2025
1 min read

FDA awards 1st national priority nod to USAntibiotics’ Augmentin XR

Roughly half a year after introducing the new regulatory pathway, the FDA has greenlit the first drug under its ultra-speedy—and controversial—Commissioner’s National Priority Voucher pilot review program. The inaugural approval under the program has gone to USAntibiotics and its domestically manufactured extended-release antibiotic Augmentin XR.

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