Notice2026-03495
Determination That Klonopin (Clonazepam) Tablets, 0.125 Milligrams and 0.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
February 23, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that KLONOPIN (clonazepam) tablets, 0.125 milligrams (mg) and 0.25 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for clonazepam tablets, 0.125 mg and 0.25 mg, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 91 Issue 35 (Monday, February 23, 2026)</title>
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[Federal Register Volume 91, Number 35 (Monday, February 23, 2026)]
[Notices]
[Pages 8493-8494]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03495]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-1808]
Determination That Klonopin (Clonazepam) Tablets, 0.125
Milligrams and 0.25 Milligrams, Were Not Withdrawn From Sale for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 or Agency) has
determined that KLONOPIN (clonazepam) tablets, 0.125 milligrams (mg)
and 0.25 mg, were not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for clonazepam tablets, 0.125 mg and 0.25
mg, if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Lars Flores, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6281, Silver Spring, MD 20993-0002, 301-
796-0724, <a href="/cdn-cgi/l/email-protection#1e727f6c6d307872716c7b6d5e787a7f3076766d30797168"><span class="__cf_email__" data-cfemail="0b676a7978256d6764796e784b6d6f6a25636378256c647d">[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).
[[Page 8494]]
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.
KLONOPIN (clonazepam) tablets, 0.125 mg and 0.25 mg, are the
subject of NDA 017533, held by Cheplapharm Arzneimittel GmbH, and
initially approved on April 9, 1997. KLONOPIN is indicated for seizure
disorders and panic disorder.
KLONOPIN (clonazepam) tablets, 0.125 mg and 0.25 mg, are currently
listed in the ``Discontinued Drug Product List'' section of the Orange
Book.
Hyman, Phelps & McNamara, P.C. submitted a citizen petition dated
June 20, 2025 (Docket No. FDA-2025-P-1808), under 21 CFR 10.30,
requesting that the Agency determine whether KLONOPIN (clonazepam)
tablets, 0.25 mg, were withdrawn from sale for reasons of safety or
effectiveness. Although the citizen petition did not address the 0.125
mg strength, that strength has also been discontinued. On our own
initiative, we have also determined whether that strength was withdrawn
for safety or effectiveness reasons.
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 KLONOPIN (clonazepam) tablets, 0.125 mg and
0.25 mg, were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
KLONOPIN (clonazepam) tablets, 0.125 mg and 0.25 mg, were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of KLONOPIN (clonazepam)
tablets, 0.125 mg and 0.25 mg, 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
these drug products were withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list KLONOPIN (clonazepam)
tablets, 0.125 mg and 0.25 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. ANDAs that refer to KLONOPIN (clonazepam) tablets, 0.125
mg and 0.25 mg, 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 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. 2026-03495 Filed 2-20-26; 8:45 am]
BILLING CODE 4164-01-P
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