Notice2026-17812
Determination That NAMENDA (Memantine Hydrochloride) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
September 1, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that NAMENDA (memantine hydrochloride) tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as the ANDAs meet relevant legal and regulatory requirements.
Full Text
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<title>Federal Register, Volume 91 Issue 168 (Tuesday, September 1, 2026)</title>
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[Federal Register Volume 91, Number 168 (Tuesday, September 1, 2026)]
[Notices]
[Pages 56149-56150]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-17812]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-P-6538]
Determination That NAMENDA (Memantine Hydrochloride) Tablets, 5
Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons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, Agency, or we) has
determined that NAMENDA (memantine hydrochloride) tablets, 5 milligrams
(mg) and 10 mg, were not withdrawn from sale for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to these drug products, and it will allow FDA to
continue to approve ANDAs that refer to the products as long as the
ANDAs meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Awo Archampong-Gray, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6243, Silver Spring, MD 20993-0002, 301-
796-0110, <a href="/cdn-cgi/l/email-protection#38794f5716794a5b5059554857565f157f4a5941785e5c591650504b165f574e"><span class="__cf_email__" data-cfemail="ca8bbda5e48bb8a9a2aba7baa5a4ade78db8abb38aacaeabe4a2a2b9e4ada5bc">[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 (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
NAMENDA (memantine hydrochloride) tablets, 5 mg and 10 mg, are the
subject of NDA 021487, held by AbbVie Inc., and initially approved on
October 16, 2003. NAMENDA is indicated for the treatment of moderate to
severe dementia of the Alzheimer's type.
NAMENDA (memantine hydrochloride) tablets, 5 mg and 10 mg, are
currently listed in the ``Discontinued Drug Product List'' section of
the Orange Book.
Newcastle Bioscience LLC submitted a citizen petition dated June 5,
2026 (Docket No. FDA-2026-P-6538), under 21 CFR 10.30, requesting that
the Agency determine whether NAMENDA (memantine hydrochloride) tablets,
5 mg and 10 mg, were voluntarily 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 NAMENDA (memantine hydrochloride) tablets, 5
mg and 10 mg, were not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that NAMENDA (memantine hydrochloride) tablets,
5 mg and 10 mg, were withdrawn for reasons of safety or effectiveness.
We have carefully reviewed our files for records concerning the
withdrawal of NAMENDA (memantine hydrochloride) tablets, 5 mg and 10
mg, from sale. We have also independently evaluated
[[Page 56150]]
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 NAMENDA (memantine
hydrochloride) tablets, 5 mg and 10 mg, 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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to these drug products. Additional ANDAs for
these drug products may also 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 these drug products 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. 2026-17812 Filed 8-31-26; 8:45 am]
BILLING CODE 4164-01-P
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