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# Impax Ursodiol Capsules Withdrawn Over BE Data
- URL: https://www.fdaweb.com/impax-ursodiol-capsules-withdrawn-over-be-data/
- Published: 2019-09-16T12:00:00.000Z
- Updated: 2026-09-15T01:50:02.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145006

*Federal Register* notice: FDA has withdrawn approval of an Impax ANDA for ursodiol capsules USP, 300 mg. Impax requested the withdrawal based on FDA’s concerns about the validity of bioequivalence data from an undisclosed contract research organization. Ursodiol is used to dissolve certain types of gallstones, to prevent gallstones from forming in obese patients who are losing weight rapidly, and to treat a certain type of liver disease (primary biliary cirrhosis). To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-09-16/pdf/2019-19908.pdf?ref=fdaweb.com).