Notice2026-08390
Determination FENOGLIDE (Fenofibrate) Tablets, 40 Milligrams and 120 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
April 30, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that FENOGLIDE (fenofibrate) tablets, 40 milligrams (mg) and 120 mg, was not withdrawn from sale for reasons of safety or effectiveness.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 83 (Thursday, April 30, 2026)</title>
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[Federal Register Volume 91, Number 83 (Thursday, April 30, 2026)]
[Notices]
[Pages 23288-23289]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08390]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-P-0655]
Determination FENOGLIDE (Fenofibrate) Tablets, 40 Milligrams and
120 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or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 FENOGLIDE (fenofibrate) tablets, 40 milligrams (mg) and
120 mg, was not withdrawn from sale for reasons of safety or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: Heather Dorsey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6269, Silver Spring, MD 20993-0002, 301-
796-3600, <a href="/cdn-cgi/l/email-protection#8bc3eeeaffe3eef9a5cfe4f9f8eef2cbedefeaa5e3e3f8a5ece4fd"><span class="__cf_email__" data-cfemail="276f4246534f42550963485554425e67414346094f4f5409404851">[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
[[Page 23289]]
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.
FENOGLIDE (fenofibrate) tablets, 40 mg and 120 mg, is the subject
of NDA 022118, held by Salix Pharmaceuticals, Inc., and initially
approved on August 10, 2007. FENOGLIDE is indicated as an adjunct to
diet to reduce triglyceride (TG) levels in adults with severe
hypertriglyceridemia (TG greater than or equal to 500 mg/deciliter
(dL)) and to reduce elevated low-density lipoprotein cholesterol (LDL-
C) in adults with primary hyperlipidemia when use of recommended LDL-C
lowering therapy is not possible.
In a letter dated September 9, 2024, Salix Pharmaceuticals, Inc.
notified FDA that FENOGLIDE (fenofibrate) tablets, 40 mg and 120 mg,
was being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
Foley & Lardner LLP submitted a citizen petition dated January 21,
2026 (Docket No. FDA-2026-P-0655), under 21 CFR 10.30, requesting that
the Agency determine whether FENOGLIDE (fenofibrate) tablets, 40 mg and
120 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 FENOGLIDE (fenofibrate) tablets, 40 mg and 120
mg, was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
this drug product was withdrawn for reasons of safety or effectiveness.
We have carefully reviewed our files for records concerning the
withdrawal of FENOGLIDE (fenofibrate) tablets, 40 mg and 120 mg, 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 FENOGLIDE
(fenofibrate) tablets, 40 mg and 120 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. 2026-08390 Filed 4-29-26; 8:45 am]
BILLING CODE 4164-01-P
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