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“… GSK hadn’t sold the drug since 1999. At the request of the Food and Drug Administration, GSK said in September it would submit its application for patients with cerebral folate transport deficiency—a rare genetic condition with similarities to autism—in a move that allowed the agency to update the label for the drug and its generic counterparts.
… Senior FDA officials said they examined scientific studies to see if they could approve leucovorin to treat autism, but didn’t come up with enough strong scientific evidence to do so.
A spokesman for the Department of Health and Human Services said GSK’s withdrawal on Thursday doesn’t affect generic versions of the drug, which already have updated labels for the genetic condition.
“GSK’s action does not affect the availability of generic leucovorin for patients with cerebral folate deficiency, or the labeling of leucovorin products,” an HHS spokesman said.
A GSK spokeswoman said the company had never intended to sell the drug again.…”



