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# Mutamycin Not Withdrawn Over Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/mutamycin-not-withdrawn-over-safety-efficacy-fda/
- Published: 2018-06-11T12:00:00.000Z
- Updated: 2026-09-15T00:12:10.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141646

*Federal Register* notice: FDA has determined that Mutamycin (mitomycin) injectable, 5mg/vial and 20mg/vial, was not withdrawn for reasons of safety or effectiveness. The determination will allow the agency to approve ANDAs that reference the products if all other legal and regulatory requirements are met. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-06-11/pdf/2018-12441.pdf?ref=fdaweb.com).