Posted by Michael Wonder on 27 Mar 2023
Delcath Systems announces FDA acceptance of new drug application resubmission of Hepzato Kit with a PDUFA date of 14 August 2023
27 March 2023 - Delcath Systems announced that the US FDA has accepted Delcath Systems' new drug application resubmission for Hepzato Kit (melphalan hydrochloride for injection/hepatic delivery system) seeking approval for the treatment of patients with unresectable hepatic dominant metastatic ocular melanoma.
The FDA also communicated to Delcath that they consider the submission a complete class 2 response and the PDUFA date for the resubmission is 14 August 2023.
