FDA Withdraws Approval of Drug Promoted as Autism Treatment

Generic versions of the drug will still be available, officials said.

The U.S. Food and Drug Administration in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

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.