The U.S. FDA has finalized its guidance on its designation process and criteria for competitive generic therapies (CGTs).
The provisions associated with CGTs are intended to incentivize effective development, efficient review, and timely market entry of drugs for which there is inadequate generic competition. A draft version of the guidance was released in February 2019.
Specifically, the guidance provides a description of the process that applicants should follow to request designation of a drug as a CGT and the criteria for designating a drug as a CGT. It also includes information on the actions FDA may take to expedite the development and review of ANDAs for drugs designated as CGTs. Finally, it provides information on how FDA implements the statutory provision for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs.
Read the full guidance