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Delcath Says FDA Oncologic Drugs Advisory Committee to Review NDA for Melblez Kit on May 2, 2013

Delcath Systems, Inc. (NASDAQ: DCTH) today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the Company's pending New Drug Application (NDA) for a drug/device combination product with the proposed trade name Melblez KitTM (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System. The ODAC meeting will be convened Thursday, May 2, 2013, to review the NDA with a proposed indication for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver. ODAC panels advise the U.S. Food and Drug Administration on the safety and efficacy of proposed new cancer therapies. The FDA is not legally bound to follow the advice of its advisory committees regarding new drug applications. Delcath's NDA was accepted by the FDA for substantive review on October 15, 2012, and was assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 15, 2013. Eamonn P. Hobbs, President & CEO of Delcath Systems, said, "Our team is actively preparing for the ODAC meeting and we look forward to presenting our data

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Posted-In: News Guidance Contracts Management Global

 

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