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# Nizoral Not Withdrawn Due to Safety/Effectiveness: FDA
- URL: https://www.fdaweb.com/nizoral-not-withdrawn-due-to-safety-effectiveness-fda/
- Published: 2017-09-01T12:00:00.000Z
- Updated: 2026-09-14T22:46:13.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139526

*Federal Register* notice: FDA has determined that Janssen Research & Development’s Nizoral (ketoconazole) tablets, 200 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination allows FDA to continue to approve ANDAs that reference Nizoral, indicated for treating the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-09-01/pdf/2017-18548.pdf?ref=fdaweb.com).