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

Regulatory NewsRegulatory News | 26 January 2021 |  By 

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 (RELATED: FDA Revises Priority ANDA Draft Guidance, Regulatory Focus 3 November 2017; FDA Finalizes Guidance on Competitive Generic Therapies, Regulatory Focus 13 March 2020).

FDA’s goal under GDUFA II is to act on 90% of priority ANDAs within 8 months with a complete pre-submission facility correspondence (PFC) in eight months instead of the standard 10 months. For CGTs, FDA offers several meetings aimed at expediting product development and says it will strive to act before a designated product’s GDUFA date but stops short of promising a shorter review.

Under FDARA, FDA is required to report on its activities related to priority generics and CGTs and FDA maintains a list of all the CGTs it has approved, including whether the product was eligible for CGT exclusivity.

In FY2020, FDA saw a sharp uptick in the number of CGTs awaiting FDA action, though that figure dropped slightly Q1 of FY2021, while the number of priority ANDAs awaiting FDA action remained consistent with FY2019 levels. On the other hand, the number of applications with both designations awaiting applicant action has ticked up slightly.


Approvals under both programs are up considerably since their inception, with 28 priority generics and 35 CGTs approved in FY2020 compared to the prior two years. FY2021 is starting off strong as well, with six priority generics and 14 CGTs approved in Q1. In FY2019, FDA approved 19 priority ANDAs and 15 CGTs, whereas in FY2018 the agency approved only three CGTs and did not approve priority ANDAs.


Among the features of CGT designation available to expedite the development of competitive generics, pre-submission meetings remain unpopular, with only a few meetings requested and held across the first three years of the program. On the other hand, product development meetings have taken off, with 25 requested and 15 held in FY2020.




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Tags: FDA, generic drugs, US

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