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# FDA Withdrawing Approval of Allergan’s Asacol
- URL: https://www.fdaweb.com/fda-withdrawing-approval-of-allergans-asacol/
- Published: 2020-12-10T12:00:00.000Z
- Updated: 2026-09-14T16:39:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148269

*Federal Register* notice: FDA is withdrawing the approval of an Allergan Pharmaceuticals International NDA for Asacol (mesalamine) delayed-release tablets, 400 mg. The withdrawal decision is based on FDA concerns about certain phthalate esters, including dibutyl phthalate (DBP), being developmental and reproductive toxicants in laboratory animals. Asacol (mesalamine) contains DBP as an inactive ingredient and FDA told the company in 2017 that the product presents a potential problem. Allergan has agreed to the withdrawal and waived its opportunity for a hearing. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-12-10/pdf/2020-27082.pdf?ref=fdaweb.com).