FDA Pulls Plug on Wellcovorin Tablets After Manufacturer Request
Published Date: 4/10/2026
Notice
Summary
GlaxoSmithKline has asked the FDA to withdraw approval for Wellcovorin tablets, which means these drugs will no longer be legally sold starting April 10, 2026. Patients and pharmacies should use up any existing stock before it expires, but no new supplies can be introduced. This change won’t stop GSK from applying again in the future if they choose to do so.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Wellcovorin Sales Stop April 10, 2026
GlaxoSmithKline’s approval for Wellcovorin (leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg base, is withdrawn as of April 10, 2026. After that date no new supplies may be introduced or delivered for introduction into interstate commerce; doing so would violate sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act.
Existing Inventory May Be Dispensed
Any Wellcovorin tablets (EQ 5 mg base and EQ 25 mg base) that are in inventory on April 10, 2026 may continue to be dispensed until they are used up, reach their expiration dates, or otherwise become violative, whichever happens first.
Withdrawal Is Without Prejudice to Refiling
The withdrawal of approval is without prejudice to refiling, so GlaxoSmithKline may apply again in the future to seek approval for Wellcovorin (leucovorin calcium) tablets.
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