[Federal Register Volume 87, Number 229 (Wednesday, November 30, 2022)]
[Notices]
[Page 73561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26057]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2855]


Mylan Institutional, Inc.; Withdrawal of Approval of a New Drug 
Application for SULFAMYLON[supreg] (Mafenide Acetate, USP) Powder for 
5% Topical Solution

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of new drug application (NDA) 019832 for SULFAMYLON[supreg] (Mafenide 
Acetate, USP) Powder for 5% Topical Solution, held by Mylan 
Institutional, Inc., a Viatris company (Mylan). Mylan has voluntarily 
requested withdrawal of this application and has waived its opportunity 
for a hearing.

DATES: Applicable November 30, 2022.

FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Office of 
Regulatory Policy, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6262, 
Silver Spring, MD 20993, 301-796-3601.

SUPPLEMENTARY INFORMATION: On June 5, 1998, the Food and Drug 
Administration (FDA) approved NDA 019832 for SULFAMYLON[supreg] 
(Mafenide Acetate, USP) Powder for 5% Topical Solution, under the 
Agency's accelerated approval regulations (see generally 21 CFR subpart 
H). It was approved for ``for use as an adjunctive topical 
antimicrobial agent to control bacterial infection when used under 
moist dressings over meshed autografts on excised burn wounds.''
    NDA 019832's accelerated approval was ``subject to the requirement 
that the applicant study the drug further, to verify and describe its 
clinical benefit, where there is uncertainty as to the relation of the 
surrogate endpoint to clinical benefit, or of the observed clinical 
benefit to ultimate outcome'' (21 CFR 314.510). To date, however, Mylan 
has not completed the required confirmatory study. Mylan acknowledged 
in its December 10, 2021, letter requesting withdrawal of approval that 
a successful confirmatory study was necessary to fulfill the 
accelerated approval requirements, but stated that conducting such a 
study is not feasible. Mylan thus requested that NDA 019832 be 
withdrawn under 21 CFR 314.150(d), and waived its right to a hearing.
    Thus, for the reasons discussed above, under 21 CFR 314.150(d), 
approval of NDA 019832 for SULFAMYLON[supreg] (Mafenide Acetate, USP) 
Powder for 5% Topical Solution, and all amendments and supplements 
thereto, is withdrawn. Distribution of SULFAMYLON[supreg] (Mafenide 
Acetate, USP) Powder for 5% Topical Solution in interstate commerce 
without an approved application is illegal and subject to regulatory 
action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 
355(a) and 331(d)).

    Dated: November 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26057 Filed 11-29-22; 8:45 am]
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