FDA Approves Alyftrek for Priority Review Voucher Redemption
January 09, 2025
January 09, 2025
WASHINGTON, Jan. 9 (TNSFR) -- The Food and Drug Administration (FDA) has approved ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor) tablets, which qualifies for the redemption of a rare pediatric disease priority review voucher. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to announce the approval of products that meet the criteria for redeeming such vouchers.
ALYFTREK, which was approved on December 20, 2024, addresses a rare pediatric disease . . .
ALYFTREK, which was approved on December 20, 2024, addresses a rare pediatric disease . . .