Delcath Systems, Inc. DCTH announced
today that the U.S. Food and Drug Administration (FDA) has accepted the
Company's New Drug Application (NDA) for its proprietary chemosaturation
system with melphalan hydrochloride for injection. The FDA has designated the
NDA for standard review. Delcath expects to be notified of its PDUFA date in
the FDA's 74-Day letter, which the Company expects to receive by the end of
October. Under the Prescription Drug User Fee Act (PDUFA), the FDA has the
goal of completing its review of applications designated for standard review
within 10 months of the NDA submission, which was submitted on August 15,
2012. The Company is seeking approval for its proprietary chemosaturation
system with melphalan hydrochloride as a treatment for patients with
unresectable metastatic melanoma in the liver.
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