Business · 15/10/2024Updated: 10/17/2026 · 1 min read
FDA Awards Priority Review Voucher to Sponsor of Rare Pediatric Disease Product AQNEURSA
Summary
The FDA has awarded a priority review voucher to IntraBio Inc., the manufacturer of AQNEURSA (levacetylleucine), a rare pediatric disease product approved on September 24, 2024, in recognition of meeting the criteria set by the Federal Food, Drug, and Cosmetic Act.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →