GlaxoSmithKline has withdrawn its new drug application for Wellcovorin (leucovorin calcium) tablets from the US FDA, marking the second time the branded product has lost its regulatory standing in the United States. The withdrawal, effective April 10, 2026, covers both the 5 mg and 25 mg tablet strengths under NDA 018342 and was initiated at GSK’s own request after the company notified the agency that the products were no longer being marketed.
The action was published in the Federal Register under 21 CFR 314.150(c), the voluntary withdrawal pathway that allows NDA holders to surrender approval without prejudice to refiling. GSK waived its right to a hearing. Any inventory of Wellcovorin tablets held on the withdrawal date may continue to be dispensed until stocks are depleted or products reach expiration, after which further distribution without an approved NDA would violate the Federal Food, Drug, and Cosmetic Act.
The regulatory history of NDA 018342 is not straightforward. The application was originally approved in 1983, when Burroughs Wellcome held the NDA, with GSK acquiring the molecule upon through acquisition in 2000. GSK first withdrew the drug in September 1999 after generic competition entered the US market around 1997. What makes the current action notable is that NDA 018342 was re-approved by the US FDA as recently as September 24, 2025, in connection with a new indication in cerebral folate transport deficiency. The FDA at that point described the action as the first approval of a treatment for patients with that condition. Less than seven months later, GSK has again surrendered the application.
That September approval followed earlier public discussion about broader potential uses of leucovorin in neurodevelopmental disorders. In September 2025, US health officials highlighted the possibility that leucovorin could benefit larger numbers of children with autism, based on small studies suggesting that some patients develop autoantibodies that interfere with folate transport to the brain, including one study that was later retracted. Subsequently, after reviewing the available evidence, the US FDA concluded that the data were sufficient only to support approval for the rare genetic form of cerebral folate deficiency caused by FOLR1 variants, and not for autism spectrum disorder more broadly.