Notice2025-22682
Determination That BACTROBAN (Mupirocin) Nasal Ointment, 2%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
December 12, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that BACTROBAN (mupirocin) nasal ointment, 2%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for mupirocin nasal ointment, 2%, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 90 Issue 237 (Friday, December 12, 2025)</title>
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[Federal Register Volume 90, Number 237 (Friday, December 12, 2025)]
[Notices]
[Page 57767]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22682]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-P-1617]
Determination That BACTROBAN (Mupirocin) Nasal Ointment, 2%, Was
Not Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that BACTROBAN (mupirocin) nasal ointment, 2%, was not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for mupirocin nasal ointment, 2%, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Iris Masucci, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002, 301-796-3600,
<a href="/cdn-cgi/l/email-protection#6b0219021845060a181e0808022b0d0f0a45030318450c041d"><span class="__cf_email__" data-cfemail="c3aab1aab0edaea2b0b6a0a0aa83a5a7a2edababb0eda4acb5">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, a drug
is removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
BACTROBAN (mupirocin) nasal ointment, 2%, is the subject of NDA
050703, held by SmithKline Beecham (Cork) Ltd., Ireland/GlaxoSmithKline
(GSK), and was initially approved on September 18, 1995. BACTROBAN
nasal ointment, 2%, is indicated for the eradication of nasal
colonization with methicillin-resistant Staphylococcus aureus (MRSA) in
adult and pediatric patients (aged 12 years and older) and healthcare
workers as part of a comprehensive infection control program to reduce
the risk of infection among patients at high risk of MRSA infection
during institutional outbreaks of infections with this microorganism.
In a correspondence dated February 9, 2018, GSK notified FDA that
BACTROBAN (mupirocin) nasal ointment, 2%, was being discontinued, and
FDA moved the drug product to the ``Discontinued Drug Product List''
section of the Orange Book. In a letter dated January 5, 2022, GSK
requested withdrawal of NDA 050703 for BACTROBAN (mupirocin) nasal
ointment, 2%, under Sec. 314.150(c) (21 CFR 314.150(c)). In the
Federal Register of August 4, 2025, FDA announced that it was
withdrawing approval of NDA 050703 upon request of GSK under Sec.
314.150(c), effective September 3, 2025.
E4 Consulting submitted a citizen petition dated June 24, 2020
(Docket No. FDA-2020-P-1617), under 21 CFR 10.30, requesting that the
Agency determine whether BACTROBAN (mupirocin) nasal ointment, 2%, was
withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that BACTROBAN (mupirocin) nasal ointment, 2%, was
not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that BACTROBAN
(mupirocin) nasal ointment, 2%, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of BACTROBAN (mupirocin) nasal ointment, 2%,
from sale. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events. We have found no
information that would indicate that this drug product was withdrawn
from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list BACTROBAN (mupirocin)
nasal ointment, 2%, in the ``Discontinued Drug Product List'' section
of the Orange Book. The ``Discontinued Drug Product List'' delineates,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness. ANDAs that
refer to BACTROBAN (mupirocin) nasal ointment, 2%, may be approved by
the Agency as long as they meet all other legal and regulatory
requirements for the approval of ANDAs. If FDA determines that labeling
for this drug product should be revised to meet current standards, the
Agency will advise ANDA applicants to submit such labeling.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-22682 Filed 12-11-25; 8:45 am]
BILLING CODE 4164-01-P
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