11/13/2023

Mafenide Acetate Powder for Solution

Products Affected - Description

- Sulfamylon topical powder for solution, Mylan (Viatris), 50 gram, packet, 5 count, NDC 51079-0624-85 - discontinued
- Mafenide acetate topical powder for solution, Ingenus Pharmaceuticals, 50 gram, packet, 5 count, NDC 50742-0310-25 - discontinued
- Mafenide acetate topical powder for solution, Par Pharmaceuticals, 50 gram, packet, 5 count, NDC 49884-0902-78 - discontinued

Reason for the Shortage

- Ingenus has discontinued mafenide powder for topical solution.
- Mylan has discontinued Sulfamylon powder for topical solution. Sulfamylon powder for solution was initially approved under the FDA accelerated approval program. The product's continued approval required a confirmatory study, which was not performed. Consequently, the product is no longer FDA approved.
- Par has discontinued mafenide powder for topical solution.
- Mafenide acetate cream is not affected by this shortage.

Available Products

- There are no presentations available

Updated

Updated November 13, 2023 by Leslie Jensen, PharmD, Drug Information Specialist. Created August 28, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2023, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

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