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# Mylan Requests Sulfamylon Withdrawal
- URL: https://www.fdaweb.com/mylan-requests-sulfamylon-withdrawal/
- Published: 2022-11-29T12:00:00.000Z
- Updated: 2026-09-14T18:07:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153279

*Federal Register* notice: FDA is withdrawing the approval of Mylan’s Sulfamylon (mafenide acetate, USP) powder for 5% topical solution after the company requested it be withdrawn. The drug was granted accelerated approval in 1998 for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds. In its letter requesting the withdrawal, the company told the agency that conducting a successful confirmatory study was not feasible, and it waived its right to a hearing. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-26057.pdf?ref=fdaweb.com).