Competitive Generic Therapies Guidance

FDA has published a guidance, Competitive Generic Therapies, describing the process applicants should follow to request the designation of a drug as a competitive generic therapy (CGT) and the criteria for giving a drug that designation. The document also has information on actions the agency may take to expedite the development and review of ANDAs for drugs designated as CGTs. And 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.

The guidance revises a 3/2020 guidance to incorporate information on the meeting types and performance goals included in the GDUFA 3 reauthorization.

The contents of the guidance are Introduction, Background, Competitive Generic Therapy Designation, Considerations for Expedited Development and Review of Competitive Generic Therapies, and Competitive Generic Therapy Exclusivity.