FDA Approves GSK Request to Withdraw Wellcovorin Leucovorin Tablets

Clinicians and oncology pharmacies who depend on leucovorin as part of chemotherapy regimens can continue prescribing and dispensing the drug without interruption. GlaxoSmithKline's withdrawal of its branded Wellcovorin (leucovorin calcium) tablets from the FDA's approval registry is an administrative business decision, not a safety recall, and generic leucovorin remains fully available on the market.

The FDA's Federal Register notice, published April 10, 2026, made the withdrawal of NDA 018342 official and confirmed that GSK had "notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn." GSK waived its right to a hearing under the applicable regulation, streamlining the procedural close. No safety finding, no clinical concern, and no manufacturing defect was cited as a basis for the action.

The notice also addressed existing supply: Wellcovorin inventory already held by hospitals, pharmacies, or distributors may continue to be dispensed until depleted or until the product reaches its expiration date. There is no mandated pull from shelves. For formulary committees and oncology pharmacists, the practical adjustment amounts to confirming procurement channels for generic leucovorin from existing suppliers, rather than any clinical protocol change.

Leucovorin, a form of folinic acid, has been used for decades alongside certain chemotherapy regimens and to treat folate-related metabolic conditions. The branded product's exit attracted more notice than a routine administrative withdrawal typically would because leucovorin had recently entered public discussion, amplified by officials and patient advocates, around its potential role in certain neurodevelopmental contexts. That elevated profile gave an otherwise unremarkable market withdrawal outsized visibility in both business and health coverage.

The FDA's Center for Drug Evaluation and Research set out compliance dates in the notice and designated a contact for further inquiry. GSK's decision to exit the branded market while generics remain unaffected reflects a pattern well-known in pharmaceutical markets: off-patent drugs that re-enter the policy spotlight can trigger regulatory and market responses that ripple across suppliers and institutions, even when no underlying safety question has been raised.