GSK Withdraws Wellcovorin NDA - Leucovorin Calcium Tablets Discontinued
Summary
FDA withdrew approval of NDA 018342 for Wellcovorin (leucovorin calcium) tablets at GSK's written request after the company notified the Agency the drug products were no longer marketed. GSK waived its opportunity for a hearing and requested withdrawal under 21 CFR 314.150(c). Existing inventory may be dispensed until depleted or until expiration dates.
What changed
FDA withdrew approval of NDA 018342 for Wellcovorin (leucovorin calcium) tablets at the manufacturer's request. GSK voluntarily discontinued marketing the drug products and waived its opportunity for a hearing under 21 CFR 314.150(c), which allows withdrawal without prejudice to future refiling.\n\nHealthcare providers and distributors holding Wellcovorin inventory may continue dispensing until supplies are exhausted or products reach their expiration dates. Any party introducing or delivering these products into interstate commerce after April 10, 2026 without an approved NDA would violate sections 505(a) and 301(d) of the FD&C Act. Patients relying on Wellcovorin should be transitioned to alternative leucovorin calcium products if available.
What to do next
- Verify whether Wellcovorin inventory is held and track remaining supply
- Cease introduction of Wellcovorin into interstate commerce after inventory depletion
- Confirm availability of alternative leucovorin calcium tablet suppliers for patients
Archived snapshot
Apr 10, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Notice
GlaxoSmithKline; Withdrawal of Approval of a New Drug Application for Wellcovorin (Leucovorin Calcium) Tablets, EQ 5 mg Base and EQ 25 mg Base
A Notice by the Food and Drug Administration on 04/10/2026
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- Public Inspection Published Document: 2026-06911 (91 FR 18472) Document Headings ###### Department of Health and Human Services
Food and Drug Administration
- Docket No. FDA-2026-N-0707 # AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
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, druginfo@fda.hhs.gov.
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 § 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 § 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
Published Document: 2026-06911 (91 FR 18472)
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