Notice2025-16863
Determination That NUTRACORT (Hydrocortisone) Topical Gel, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
September 3, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that NUTRACORT (hydrocortisone) topical gel, 1%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for NUTRACORT (hydrocortisone) topical gel, 1%, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 90 Issue 168 (Wednesday, September 3, 2025)</title>
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[Federal Register Volume 90, Number 168 (Wednesday, September 3, 2025)]
[Notices]
[Pages 42590-42591]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16863]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-0441]
Determination That NUTRACORT (Hydrocortisone) Topical Gel, 1%,
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 NUTRACORT (hydrocortisone) topical gel, 1%, was not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for NUTRACORT (hydrocortisone) topical gel, 1%, if
all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Beth Holck, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 240-402-7133,
<a href="/cdn-cgi/l/email-protection#10527564783e587f7c737b507674713e7878633e777f66"><span class="__cf_email__" data-cfemail="420027362a6c0a2d2e2129022426236c2a2a316c252d34">[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, drugs
are 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 (21 CFR 314.161). FDA may not approve an ANDA that does not refer
to a listed drug.
NUTRACORT (hydrocortisone) topical gel, 1%, is the subject of ANDA
084698, held by Healthpoint Ltd., and initially approved on January 6,
1976. NUTRACORT is indicated for relief of the inflammatory and
pruritic manifestations of corticosteroid-responsive dermatoses.
In a letter dated August 26, 1993, Galderma Laboratories, Inc.,
notified FDA that NUTRACORT (hydrocortisone) topical gel, 1%, was being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book.
Epstein, Becker & Green, P.C., submitted a citizen petition dated
February 17, 2025 (Docket No. FDA-2025-P-0441), under 21 CFR 10.30,
requesting that the Agency determine whether NUTRACORT (hydrocortisone)
topical gel, 1%, 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 NUTRACORT (hydrocortisone) topical gel, 1%,
was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
NUTRACORT (hydrocortisone) topical gel, 1%, was withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of NUTRACORT (hydrocortisone) topical
gel, 1%, from sale. We have also independently evaluated relevant
literature and data for possible postmarketing adverse events. We have
reviewed the available evidence and determined that this drug product
was not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list NUTRACORT
(hydrocortisone) topical gel, 1%, 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
[[Page 42591]]
from marketing for reasons other than safety or effectiveness. ANDAs
that refer to this drug product 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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16863 Filed 9-2-25; 8:45 am]
BILLING CODE 4164-01-P
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