Impax Pharmaceuticals, the branded products division of Impax Laboratories, IPXL today announced that the U.S. Food and Drug Administration
(FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its
review of the Rytary^TM (IPX066) New Drug Application (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^TM 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.
About Rytary^TM (IPX066)
Rytary^TM 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^TM has been licensed to GlaxoSmithKline (GSK) for countries outside the
U.S. and Taiwan for development and marketing.
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