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# Draft Guide on Competitive Generic Therapies
- URL: https://www.fdaweb.com/draft-guide-on-competitive-generic-therapies/
- Published: 2019-02-19T12:00:00.000Z
- Updated: 2026-09-15T01:05:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143406

*Federal Register* notice: FDA has made available a draft guidance entitled “Competitive Generic Therapies” that is intended to help expedite the development and review of certain ANDAs citing reference products that have inadequate generic competition. The document provides a description of the process that applicants should follow to request designation of a drug as a competitive generic therapy and the criteria for designating such a drug. It also includes information on the actions FDA may take to expedite an ANDA’s development and review. Additionally, the draft provides information on how FDA implements the statutory provisions providing for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for such designated drugs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-02-19/pdf/2019-02598.pdf?ref=fdaweb.com).