Closing The Books On GDUFA II: How Generics Fared At US FDA Over The Last Five Years

Approval and submission data indicate steady trends aside from one outlier year.

generic drugs bottle
About 16% of ANDA approvals in FY 2022 were first-time generic drugs. • Source: Shutterstock

Sponsors sent nearly 4,500 ANDAs and the US Food and Drug Administration approved nearly 3,900 throughout the last five-year generic drug user fee cycle.

Agency data suggests a mostly steady volume of ANDA approvals and submissions during the program cycle, save for fiscal year...

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