Opportunity
Federal Register #Docket No. FDA-2026-N-0707
FDA Withdrawal of Approval for GlaxoSmithKline Wellcovorin Tablets
Buyer
Food and Drug Administration
Posted
April 10, 2026
Identifier
Docket No. FDA-2026-N-0707
This notice announces the FDA's withdrawal of approval for Wellcovorin (leucovorin calcium) tablets, previously manufactured by GlaxoSmithKline (GSK). - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEM Mentioned: - GlaxoSmithKline, LLC (GSK) - Products/Services: - Wellcovorin (leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg base - All strengths and dosage forms under NDA 018342 - Notable Details: - GSK requested withdrawal as these products are no longer marketed - This is an administrative withdrawal of drug approval, not a procurement or award - No products or services are being solicited or purchased
Description
The Food and Drug Administration (FDA) is withdrawing approval of the new drug application (NDA) for Wellcovorin (leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg base, held by GlaxoSmithKline (GSK). GSK notified the FDA that these drug products are no longer marketed and requested withdrawal of the approval. The withdrawal is effective as of April 10, 2026, and the approval withdrawal is without prejudice to refiling. This notice informs the public of the withdrawal based on GSK's notification.