The U.S. Food and Drug Administration has approved a version of leucovorin made by GlaxoSmithKline, years after the company pulled the drug from consideration when it stopped manufacturing it.

The announcement, published Monday in the Federal Register ahead of a speech by President Donald Trump, cited data from 40 patients with a rare disorder called cerebral folate deficiency, which can cause neurological symptoms sometimes seen in people with autism.

The move highlights renewed attention on leucovorin, also known as folinic acid, and whether it might help some children with autism.

Why It Matters

President Trump on Monday used the White House podium to promote unproven links between Tylenol, vaccines and autism, offering no new evidence.

He urged women to avoid acetaminophen, com

See Full Page