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# Efudex Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/efudex-not-withdrawn-due-to-safety-efficacy/
- Published: 2021-07-29T12:00:00.000Z
- Updated: 2026-09-14T17:08:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149818

*Federal Register* notice: FDA has determined that Bausch Health America’s Efudex (fluorouracil) topical solution, 5%, was not withdrawn from sale for reasons of safety or effectiveness. The determination means that FDA can continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. The product is indicated for the topical treatment of multiple actinic or solar keratoses, and treatment of superficial basal cell carcinomas. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-07-28/pdf/2021-16037.pdf?ref=fdaweb.com).