Notice2026-07451
Determination That REVIA (Naltrexone Hydrochloride) Tablets, 50 Milligrams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
April 16, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that REVIA (naltrexone hydrochloride) tablets, 50 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness.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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Full Text
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<title>Federal Register, Volume 91 Issue 73 (Thursday, April 16, 2026)</title>
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[Federal Register Volume 91, Number 73 (Thursday, April 16, 2026)]
[Notices]
[Pages 20471-20472]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07451]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-4151]
Determination That REVIA (Naltrexone Hydrochloride) Tablets, 50
Milligrams Was Not Withdrawn From Sale for Reasons of Safety or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 REVIA (naltrexone hydrochloride) tablets, 50 milligrams
(mg), was not withdrawn from sale for reasons of safety or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 this drug product, and it will allow FDA to
continue to approve ANDAs that refer to the product as long as they
meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Molly Arndt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6281, Silver Spring, MD 20993-0002, 240-
402-6919, <a href="/cdn-cgi/l/email-protection#2c4143404055024d5e4248586c4a484d0244445f024b435a"><span class="__cf_email__" data-cfemail="305d5f5c5c491e51425e5444705654511e5858431e575f46">[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.
REVIA (naltrexone hydrochloride) tablets, 50 mg, is the subject of
NDA 018932, held by Teva Women's Health, Inc., and initially approved
on November 20, 1984. REVIA is indicated for the treatment of alcohol
dependence and for the blockade of the effects of exogenously
administered opioids.
In a letter dated May 16, 2018, Teva Women's Health, Inc. requested
withdrawal of NDA 018932 for REVIA (naltrexone hydrochloride) tablets,
50 mg. In the Federal Register of April 1, 2019 (84 FR 12262), FDA
announced that it was withdrawing approval of NDA 018932, effective May
1, 2019.
Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated
September 22, 2025 (Docket No. FDA-2025-P-4151), under 21 CFR 10.30,
requesting that the Agency determine whether REVIA (naltrexone
hydrochloride) tablets, 50 mg, 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 REVIA (naltrexone hydrochloride) tablets, 50
mg, was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
REVIA (naltrexone hydrochloride) tablets, 50 mg, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of REVIA (naltrexone
hydrochloride) tablets, 50 mg, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have
[[Page 20472]]
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 REVIA (naltrexone
hydrochloride) tablets, 50 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 this drug product. Additional ANDAs for
this drug product 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 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. 2026-07451 Filed 4-15-26; 8:45 am]
BILLING CODE 4164-01-P
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