Generic versions of the drug will still be available, officials said.
Federal regulators on April 10 said they withdrew approval of a drug made by GlaxoSmithKline that officials had said may be able to treat many cases of autism spectrum disorder.
The Food and Drug Administration said in a regulatory notice that it was withdrawing approval for GSK’s Wellcovorin (leucovorin calcium) tablets.
GSK told officials that the drug was no longer marketed and requested the withdrawal, according to the notice.
“Because Wellcovorin is no longer marketed or manufactured by GSK, the [new drug application] has been withdrawn,” a spokesperson for GSK, which has not marketed Wellcovorin since 1997, told The Epoch Times in an email.
Leucovorin, or folinic acid, has long been available in generic form. The withdrawal “does not affect the availability of generic leucovorin for patients with cerebral folate deficiency, or the labeling of leucovorin products,” a spokesperson for the FDA told The Epoch Times in an email.
Officials said in 2025 that the drug appeared to treat autism symptoms.
“We are going to approve a drug called leucovorin for the treatment of autism, and it may help 50 to 60 percent of kids with autism,” FDA Commissioner Dr. Marty Makary said on C-SPAN.
Health Secretary Robert F. Kennedy Jr. said at a press conference that leucovorin was an “exciting therapy that may benefit large numbers of children who suffer from autism.”
The FDA approved leucovorin on March 10 for treating cerebral folate deficiency in people who have a confirmed variant in the folate receptor 1 gene. GSK submitted the application for approval, based on a request from the government.
“Right now, we don’t have sufficient data to say that we could establish efficacy for autism more broadly,” an FDA official told reporters on a call in March.
Kennedy and other officials have said that it is important to identify treatments for, and causes of, autism, the prevalence of which has risen to one in 31 children in the United States.
Dr. David Danish, a psychiatrist and president of Philadelphia Integrative Psychiatry, who prescribes leucovorin to some of his patients, told The Epoch Times via email that “the science is clear.”
