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GSK to submit label update for Leucovorin at FDA's request, does not intend to market it for autism
Youtube· 2025-09-22 22:20
Group 1 - The FDA is moving forward with the approval process for Lucavorin to treat some symptoms of autism, which is significant for the generics market [2][3] - GSK previously marketed Lucavorin but pulled it from the market in 1997 and currently has no plans to reintroduce it, even if the FDA updates the label for autism treatment [2][3] - The update of the drug label is crucial as it will allow generics to be marketed for autism treatment, although GSK itself will not participate in this market [3]