Delcath Systems makes new drug application resubmission for Hepzato Kit

Delcath Systems submitted a new drug application – NDA – resubmission to the FDA for the HEPZATO Kit seeking approval for the treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma. The resubmission is in response to a September 12, 2013 Complete Response Letter from the FDA. The NDA resubmission contains comprehensive data and information to address all issues identified in the CRL. The FDA is expected to determine whether the resubmission constitutes a complete response and is eligible for review within 30 days. Once accepted for review by the FDA, a new PDUFA action date will be established for the HEPZATO Kit application.