> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Competitive Generic Therapies Guidance
- URL: https://www.fdaweb.com/competitive-generic-therapies-guidance/
- Published: 2020-03-16T12:00:00.000Z
- Updated: 2026-09-14T16:07:23.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146331

*Federal Register* notice: FDA has made available a final guidance entitled “Competitive Generic Therapies.” The document describes the process that applicants should follow to request designation of a drug as a competitive generic therapy (CGT) and the criteria for designating one. In addition, it includes information on the actions that FDA may take to expedite ANDA development and review for a CGT-designated drug. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-03-16/pdf/2020-05293.pdf?ref=fdaweb.com).