FDA Awards Priority Review Voucher to Vertex Pharmaceutical for Rare Pediatric Disease Product SYMDEKO

Summary

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