Zevra Therapeutics ( NASDAQ: ZVRA ) on Tuesday said that the U.S. Food and Drug Administration (FDA) said that it would convene a meeting with the Genetic Metabolic Diseases Advisory Committee (GeMDAC) on August 2, 2024, to review the New Drug Application (NDA) for arimoclomol.
The company added that the committee would review the NDA for arimoclomol as an orally delivered, first-in-class treatment for Niemann-Pick disease type C. The NDA for arimoclomol has been assigned a Prescription Drug User Fee Act (PDUFA) action date of September 21, 2024. Press release.
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