Medexus Provides Update on Treosulfan NDA Review Process and Extended PDUFA Goal Date
Medexus Pharmaceuticals has been informed by medac that the FDA extended the treosulfan NDA review period by three months to January 30, 2025, due to additional data analysis required. Medexus remains prepared for a potential US approval and commercial launch in H1 2025.
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Medexus Provides Update on Treosulfan NDA Review Process and Extended PDUFA Goal Date
Medexus Pharmaceuticals has been informed by medac that the FDA extended the treosulfan NDA review period by three months to January 30, 2025, due to additional data analysis required. Medexus remains prepared for a potential US approval and commercial launch in H1 2025.