FDA Awards Priority Review Voucher to Asklepion Pharmaceuticals for Rare Pediatric Disease Product

Summary

The US Food and Drug Administration (FDA) has issued a priority review voucher to Asklepion Pharmaceuticals, LLC, for its application of CHOLBAM, a rare pediatric disease product, following a review of the product's eligibility under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Food and Drug Administration Safety and Innovation Act (FDASIA).