Notice2026-03213
Determination That TOLECTIN DS (Tolmetin Sodium) Capsule, Equivalent to 400 Milligrams Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
February 18, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that TOLECTIN DS (tolmetin sodium) capsule, equivalent to (EQ) 400 milligrams (mg) base, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for tolmetin sodium, capsule, EQ 400 mg base, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 91 Issue 32 (Wednesday, February 18, 2026)</title>
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[Federal Register Volume 91, Number 32 (Wednesday, February 18, 2026)]
[Notices]
[Pages 7500-7501]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03213]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-3575]
Determination That TOLECTIN DS (Tolmetin Sodium) Capsule,
Equivalent to 400 Milligrams Base, Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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[[Page 7501]]
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has
determined that TOLECTIN DS (tolmetin sodium) capsule, equivalent to
(EQ) 400 milligrams (mg) base, was not withdrawn from sale for reasons
of safety or effectiveness. This determination will allow FDA to
approve abbreviated new drug applications (ANDAs) for tolmetin sodium,
capsule, EQ 400 mg base, if all other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT: Sungjoon Chi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6216, Silver Spring, MD 20993-0002, 240-
402-9674, <a href="/cdn-cgi/l/email-protection#06557368616c69696828456e6f46606267286e6e7528616970"><span class="__cf_email__" data-cfemail="88dbfde6efe2e7e7e6a6cbe0e1c8eeece9a6e0e0fba6efe7fe">[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.
TOLECTIN DS (tolmetin sodium) capsule, EQ 400 mg base, is the
subject of NDA 018084, held by Ortho-McNeil-Janssen Pharmaceuticals,
Inc., and initially approved on October 30, 1979. TOLECTIN DS is
indicated for the relief of signs and symptoms of rheumatoid arthritis
and osteoarthritis. TOLECTIN DS is indicated in the treatment of acute
flares and the long-term management of the chronic disease. TOLECTIN DS
is also indicated for treatment of juvenile rheumatoid arthritis. The
safety and effectiveness of TOLECTIN DS have not been established in
pediatric patients under 2 years of age.
In a letter dated May 29, 2008, Johnson & Johnson Pharmaceutical
Research & Development, L.L.C., on behalf of Ortho-McNeil-Janssen
Pharmaceuticals, Inc., requested withdrawal of NDA 018084 for TOLECTIN
DS (tolmetin sodium) capsule, EQ 400 mg base. In the Federal Register
of June 8, 2011 (76 FR 33310), FDA announced that it was withdrawing
approval of NDA 018084, effective July 8, 2011.
Senores Pharmaceuticals, Inc., submitted a citizen petition dated
September 5, 2025 (Docket No. FDA-2025-P-3575), under 21 CFR 10.30,
requesting that the Agency determine whether TOLECTIN DS (tolmetin
sodium) capsule, EQ 400 mg base, 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 TOLECTIN DS (tolmetin sodium) capsule, EQ 400
mg base, was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
TOLECTIN DS (tolmetin sodium) capsule, EQ 400 mg base, was withdrawn
for reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of TOLECTIN DS (tolmetin
sodium) capsule, EQ 400 mg base, 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 TOLECTIN DS (tolmetin
sodium) capsule, EQ 400 mg base, 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 TOLECTIN DS (tolmetin sodium)
capsule, EQ 400 mg base, 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. 2026-03213 Filed 2-17-26; 8:45 am]
BILLING CODE 4164-01-P
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