USA – A look at FDA’s data on priority and competitive generics

Three years into the second Generic Drug User Fee Amendments (GDUFA II) program, the US Food and Drug Administration (FDA) has seen the number of priority and competitive generic therapy (CGT) abbreviated new drug applications (ANDAs) approved or under review rise as generic drugmakers continue to pursue both designations.

The FDA Reauthorization Act of 2017 (FDARA), which reauthorized GDUFA for five years, includes provisions to shorten the reviews of certain ANDAs by two months under a priority review program and introduced the CGT designation to increase competition for drugs with only one generic competitor on the market. (RELATED: FDA Revises Priority ANDA Draft GuidanceRegulatory Focus 3 November 2017; FDA Finalizes Guidance on Competitive Generic TherapiesRegulatory Focus 13 March 2020)…