Issue Date: October 5, 2022
Issued by: Center for Drug Evaluation and Research
Topic(s): Drug Competition Action Plan, Generic Drugs
Status: Final
Competitive Generic Therapies
The FDA Reauthorization Act of 2017, or FDARA, created a pathway by which FDA may, at the request of the applicant, designate a drug with “inadequate generic competition” as a competitive generic therapy (CGT). At the request of the applicant, FDA may also expedite the development and review of an abbreviated new drug application (ANDA) for a drug designated as a CGT. This 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. This guidance revises the guidance of the same title issued in March 2020. This revision is being issued to incorporate information on the meeting types and performance goals included in the Generic Drug User Fee Amendments (GDUFA) Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter).
Download the Guidance Document
