Impax Pharmaceuticals, the branded products division of Impax Laboratories Inc. (IPXL) announced that the U.S. Food and Drug Administration or FDA has extended the Prescription Drug User Fee Act or PDUFA date for its review of the Rytary or IPX066 New Drug Application or NDA from October 21, 2012, to January 21, 2013.
The FDA notified Impax that its September 28, 2012 submission of requested information on an excipient in the Rytary formulation to the FDA has been designated as a major amendment. Since the receipt date of this additional information is within three months of the PDUFA date, the FDA has exercised its option to extend the PDUFA date to review the information. No new clinical trials or studies have been requested by the FDA.
Rytary is an investigational extended release capsule formulation of carbidopa-levodopa for the treatment of idiopathic Parkinson's disease. It is not approved or licensed anywhere in the world. Results from the pivotal phase III studies of IPX066, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have previously been announced.
Rytary has been licensed to GlaxoSmithKline (GSK, GSK.L) for countries outside the U.S. and Taiwan for development and marketing.
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