Competitive Generic Therapies Process Guidance

FDA has released a draft guidance, Competitive Generic Therapies, describing the process that applicants should follow to request designation of a drug as a competitive generic therapy with inadequate generic competition under the FDA Reauthorization Act of 2017. The document includes the criteria for designating a drug as a competitive generic therapy and also includes information on the actions the agency may take to expedite development and review of ANDAs for designation as competitive generic therapies. And it contains information on how FDA implements the statutory provision for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for competitive generic therapies.

Guidance contents include: Introduction, Background, Competitive Generic Therapy Designation, Considerations for Expedited Development and Review of Competitive Generic Therapies, and Competitive Generic Therapy Exclusivity.