Raptor Pharmaceutical Corp.
RPTP, today announced that the U.S. Food
and Drug Administration ("FDA") will require additional time to complete its
review of the New Drug Application ("NDA") for RP103 (PROCYSBI™), for the
potential treatment of nephropathic cystinosis. In a notice received today
from the FDA, the initial Prescription Drug User Fee Act ("PDUFA") goal date
has been extended from January 30, 2013 to April 30, 2013. The three month
extension is a standard extension period.
The FDA exercised its option to extend the PDUFA goal date to provide more
time to complete the review of information submitted within three months of
the PDUFA date. The agency has not asked for additional studies.
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