Delcath Says FDA Posted Briefing Documents Ahead of ODAC Meeting

Loading...
Loading...
Delcath Systems, Inc.
DCTH
today announced that the U.S. Food and Drug Administration (FDA) has published on its website the briefing documents for the upcoming May 2, 2013 Oncologic Drugs Advisory Committee (ODAC) meeting. The ODAC will review Delcath's New Drug Application (NDA) for the marketing approval of MelblezTM Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), the Company's proprietary drug/device combination product for the treatment of patients with unresectable ocular melanoma metastatic to the liver. In addition to the briefing materials, the FDA plans to provide a live webcast of the meeting. The briefing materials from Delcath and the FDA, and information regarding the webcast including the web address for the webcast, can be accessed on the FDA webpage at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/ucm341089.htm
Market News and Data brought to you by Benzinga APIs
Posted In: NewsFDA
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...