FDA has withdrawn approval of GSK’s Wellcovorin (leucovorin calcium) tablets after the company requested removal following discontinuation. The sponsor-initiated withdrawal took effect April 10, 2026.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration has withdrawn approval of the new drug application (NDA) for Wellcovorin (leucovorin calcium) tablets held by GlaxoSmithKline after the company informed the agency that the product is no longer marketed and requested withdrawal. The action applies to Wellcovorin tablets equivalent to 5 mg base and 25 mg base and became effective April 10, 2026.
According to the Federal Register notice, GlaxoSmithKline notified the agency in writing that Wellcovorin (leucovorin calcium) tablets were discontinued and requested withdrawal under 21 CFR 314.150(c), which allows approval to be withdrawn when a sponsor confirms a product is no longer marketed. The company also waived its opportunity for a hearing, enabling the FDA to finalize the withdrawal.
As a result, approval of NDA 018342, including all amendments and supplements associated with the leucovorin product, has been withdrawn. Existing inventory may continue to be dispensed until supplies are exhausted, products reach expiration or otherwise become noncompliant.
Leucovorin, also known as folinic acid, is a reduced form of folate that restores folate activity and is commonly used to counteract the effects of folate antagonists. Historically, leucovorin has been used to reduce toxicity associated with methotrexate therapy, reverse effects of folic acid antagonists, and as part of combination regimens in oncology. The therapy has also been used in conditions involving impaired folate transport to the central nervous system.
Interest in leucovorin expanded in recent years due to its role in cerebral folate deficiency, a condition that can present with developmental delay, seizures, movement disorders, and autistic features. Because leucovorin can bypass impaired folate transport mechanisms, it has been evaluated in patients with neurological symptoms linked to folate receptor autoantibodies or genetic variants. This led to discussion of its potential role in subsets of patients with autism spectrum features associated with cerebral folate deficiency, although regulatory authorization has been limited to defined medical conditions.
Earlier in 2026, the FDA approved leucovorin calcium as the first treatment for rare FOLR1-related cerebral folate deficiency, a genetic disorder caused by variants affecting folate receptor alpha–mediated transport into the brain. The approval marked the first authorized therapy specifically targeting this condition, which is associated with severe neurological impairment including developmental delay, seizures, and autistic features.
The withdrawal of the Wellcovorin NDA reflects discontinuation of the specific GlaxoSmithKline branded product rather than a safety concern for leucovorin. The action does not affect other approved leucovorin products, including generic leucovorin calcium formulations marketed by multiple manufacturers, which remain available for approved indications.
Reference
GlaxoSmithKline; Withdrawal of Approval of a New Drug Application for Wellcovorin (Leucovorin Calcium) Tablets, EQ 5 mg Base and EQ 25 mg Base, 10 April 2026, https://www.govinfo.gov/content/pkg/FR-2026-04-10/pdf/2026-06911.pdf
FDA Approves Wellcovorin (Leucovorin Calcium) as First Treatment for Rare FOLR1-Related Cerebral Folate Deficiency, 10 March 2026, https://pharmacally.com/fda-approves-wellcovorin-leucovorin-calcium-as-first-treatment-for-rare-folr1-related-cerebral-folate-deficiency/
FDA Takes Action to Make a Treatment Available for Autism Symptoms, 22 September 2025, https://www.fda.gov/news-events/press-announcements/fda-takes-action-make-treatment-available-autism-symptoms
US Prescribing Information of Wellcovorin, https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/018342s015lbl.pdf
About the Writer
Sana Jamil Khan is a B.Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.
