Notice2025-23408
Determination That EFFEXOR XR (Venlafaxine Hydrochloride) Extended-Release Capsule, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Published
December 19, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that EFFEXOR XR (venlafaxine hydrochloride) extended-release capsule, 100 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness.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 90 Issue 242 (Friday, December 19, 2025)</title>
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[Federal Register Volume 90, Number 242 (Friday, December 19, 2025)]
[Notices]
[Pages 59528-59529]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23408]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-1304]
Determination That EFFEXOR XR (Venlafaxine Hydrochloride)
Extended-Release Capsule, 100 Milligrams, Was Not Withdrawn From Sale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 EFFEXOR XR (venlafaxine hydrochloride) extended-release
capsule, 100 milligrams (mg), was not withdrawn from sale for reasons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: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
<a href="/cdn-cgi/l/email-protection#c291b6a3a1bbec89a3aca782a4a6a3ecaaaab1eca5adb4"><span class="__cf_email__" data-cfemail="481b3c292b31660329262d082e2c296620203b662f273e">[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
[[Page 59529]]
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.
EFFEXOR XR (venlafaxine hydrochloride) extended-release capsule,
100 mg, is the subject of NDA 020699, held by Upjohn US, and initially
approved on October 20, 1997. EFFEXOR XR is indicated in adults for the
treatment of major depressive disorder, generalized anxiety disorder,
social anxiety disorder and panic disorder. EFFEXOR XR (venlafaxine
hydrochloride) extended-release capsule, 100 mg, is currently listed in
the ``Discontinued Drug Product List'' section of the Orange Book.
SciRegs International, Inc., on behalf of Inventia Healthcare
Limited, submitted a citizen petition dated May 16, 2025 (Docket No.
FDA-2025-P-1304) under 21 CFR 10.30, requesting that the Agency
determine whether EFFEXOR XR (venlafaxine hydrochloride) extended-
release capsule, 100 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 EFFEXOR XR (venlafaxine hydrochloride)
extended-release capsule, 100 mg, was not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that EFFEXOR XR (venlafaxine hydrochloride)
extended-release capsule, 100 mg, was withdrawn for reasons of safety
or effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of EFFEXOR XR (venlafaxine hydrochloride)
extended-release capsule, 100 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
this drug product was withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list EFFEXOR XR
(venlafaxine hydrochloride) extended-release capsule, 100 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.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-23408 Filed 12-18-25; 8:45 am]
BILLING CODE 4164-01-P
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