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FDA Limits Leucovorin Approval to Rare Folate Deficiency Disorder

FDA Clears Leucovorin for an Ultra-Rare Disorder — Not for Autism What You Need to Know at a Glance The FDA has approved leucovorin for a very rare genetic condition, not for autism. The newly approved use is for cerebral folate deficiency linked to a FOLR1 gene variant, an ultra-rare disorder affecting fewer than 1

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