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Home » FDA OKs Metabolism Disorder Drug, Triggers End of Pediatric Priority Review Program
FDA OKs Metabolism Disorder Drug, Triggers End of Pediatric Priority Review Program
The FDA approved Asklepion Pharmaceuticals’ Cholbam, the first treatment for children and adults with single-enzyme bile acid disorders and peroxisomal disorders, under its pediatric rare disease priority review voucher program. Under the terms Congress set for the program, the FDA must now phase it out within 12 months unless it is reauthorized.