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# Asacol Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/asacol-not-withdrawn-due-to-safety-efficacy/
- Published: 2023-02-22T12:00:00.000Z
- Updated: 2026-09-14T18:16:53.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153827

*Federal Register* notice: FDA has determined that Allergan’s Asacol HD (mesalamine) delayed-release tablet, 800 mg, was not withdrawn due to safety or effectiveness reasons. The determination means that FDA will approve ANDAs as long as they meet relevant legal and regulatory requirements. Asacol HD is indicated for treating moderately active ulcerative colitis in adults. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-02-21/pdf/2023-03521.pdf?ref=fdaweb.com).