Delcath Says FDA Designated NDA for Standard Review; Expects to Get 74 Day Letter by the End of October
Delcath Systems, Inc. (NASDAQ: 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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