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# Danicrine Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/danicrine-not-withdrawn-due-to-safety-efficacy/
- Published: 2018-08-23T12:00:00.000Z
- Updated: 2026-09-15T00:27:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142185

*Federal Register* notice: FDA has determined that Danocrine (danazol) Capsules, 50mg, 100mg, and 200mg, were not withdrawn from sale for reasons of safety or effectiveness, except for an indication for fibrocystic breast disease that was withdrawn for reasons of safety or effectiveness. The determination means that FDA will not begin procedures to suspend ANDA approvals that refer to the drug product and have removed the indication for fibrocystic breast disease. It also will allow the agency to continue to approve ANDAs that reference the drug as long as they meet relevant legal and regulatory requirements. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-08-22/pdf/2018-18081.pdf?ref=fdaweb.com).