Posted by Michael Wonder on 16 Feb 2023
Delcath Systems announces new drug application resubmission for Hepzato Kit
14 February 2023 - Delcath Systems announced it submitted a new drug application resubmission to the US FDA for the Hepzato Kit (melphalan hydrochloride for injection/hepatic delivery system) seeking approval for the treatment of patients with unresectable hepatic dominant metastatic ocular melanoma.
The resubmission is in response to a 12 September 2013 complete response letter from the FDA.
