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.
GSK, which did not respond to a request for comment by the time of publication, has said it has not marketed Wellcovorin since 1997.
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….