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Delcath Systems Inc Receives Complete Response Letter From FDA For Melbleztm Kit New Drug Application


Friday, 13 Sep 2013 06:00am EDT 

Delcath Systems, Inc announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) received September 12, 2013 regarding the New Drug Application (NDA) for Delcath's MelblezTM Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System) for the treatment of patients with unresectable ocular melanoma metastatic to the liver. 

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