Notice2026-06911
GlaxoSmithKline; Withdrawal of Approval of a New Drug Application for Wellcovorin (Leucovorin Calcium) Tablets, EQ 5 mg Base and EQ 25 mg Base
Primary source
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Published
April 10, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for Wellcovorin (leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg base, held by GlaxoSmithKline, LLC, 2020 Walnut Street, Philadelphia, PA 19104 (GSK). GSK notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Full Text
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[Federal Register Volume 91, Number 69 (Friday, April 10, 2026)]
[Notices]
[Page 18472]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-06911]
[[Page 18472]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0707]
GlaxoSmithKline; Withdrawal of Approval of a New Drug Application
for Wellcovorin (Leucovorin Calcium) Tablets, EQ 5 mg Base and EQ 25 mg
Base
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of a new drug application (NDA) for Wellcovorin
(leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg base, held by
GlaxoSmithKline, LLC, 2020 Walnut Street, Philadelphia, PA 19104 (GSK).
GSK notified the Agency in writing that the drug products were no
longer marketed and requested that the approval of the applications be
withdrawn.
DATES: Approval is withdrawn as of April 10, 2026.
FOR FURTHER INFORMATION CONTACT: Kimberly Thomas, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002, 301-796-3601,
<a href="/cdn-cgi/l/email-protection#9afee8effdf3f4fcf5dafcfefbb4f2f2e9b4fdf5ec"><span class="__cf_email__" data-cfemail="adc9dfd8cac4c3cbc2edcbc9cc83c5c5de83cac2db">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: GSK has informed FDA that for Wellcovorin
(leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg base, is no
longer marketed and have requested that FDA withdraw approval of the
applications under the process in Sec. 314.150(c) (21 CFR 314.150(c)).
GSK has also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
Therefore, approval of NDA 018342, and all amendments and
supplements thereto, is hereby withdrawn as of April 10, 2026. Approval
of the entire application is withdrawn, including any strengths and
dosage forms inadvertently missing from this notice. Introduction or
delivery for introduction into interstate commerce of Wellcovorin
(leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg base, without
an approved NDA violates sections 505(a) and 301 (d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Any
Wellcovorin (leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg
base, that is in inventory on April 10, 2026 may continue to be
dispensed until the inventories have been depleted or the drug products
have reached their expiration dates or otherwise become violative,
whichever occurs first.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-06911 Filed 4-9-26; 8:45 am]
BILLING CODE 4164-01-P
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