Posted by Michael Wonder on 06 Jun 2024
FDA accepts for review treosulfan NDA resubmission
6 June 2024 - Today, Medexus Pharmaceuticals was informed by medac, licensor of Medexus's commercialisation rights to treosulfan, that the US FDA has accepted for review medac's April 2024 resubmission of the new drug application for treosulfan.
Medexus expects that the FDA will complete its review of the treosulfan new drug application and issue a decision by 30 October 2024.
