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# Nizoral Not Withdrawn Due to Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/nizoral-not-withdrawn-due-to-safety-efficacy-fda/
- Published: 2019-06-11T12:00:00.000Z
- Updated: 2026-09-15T01:31:57.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144303

*Federal Register* notice: FDA has determined that Johnson & Johnson’s Nizoral (ketoconazole) topical cream 2% was not withdrawn from sale for safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Nizoral was approved in 1985, and is indicated for the topical treatment of tinea corporis, tinea cruris, and tinea pedis caused by *Trichophyton* rubrum, *T. mentagrophytes*, and *Epidermophyton floccosum*. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-06-11/pdf/2019-12308.pdf?ref=fdaweb.com).