Delcath Systems announces US FDA acceptance of Hepzato Kit new drug application resubmission


Delcath Systems, Inc.Delcath Systems has announced in a company press release that the US Food and Drug Administration (FDA) has accepted its (Delcath’s) 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 (mOM).

The US FDA also communicated to Delcath that its considers the submission a complete class 2 response and the Prescription Drug User Fee Act (PDUFA) date for the resubmission is 14 August 2023.

“The FDA’s acceptance of the [new drug application] resubmission is a significant milestone for Delcath and we look forward to working with the agency throughout its review of the application,” stated Gerard Michel, Delcath’s chief executive officer.  “We believe that Hepzato, if approved, will be an important option for treating patients with mOM.”


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