Business · 15/10/2024Updated: 10/17/2026 · 1 min read
FDA Awards Priority Review Voucher for Rare Pediatric Disease Product MIPLYFFA (Arimoclomol)
Summary
The FDA is issuing a priority review voucher to the sponsor of a rare pediatric disease product application for MIPLYFFA (arimoclomol), a drug approved on September 20, 2024, manufactured by Zevra Denmark AS, following the Federal Food, Drug, and Cosmetic Act's criteria.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →