Cephalon, Inc. (CEPH) said that the U.S. Food and Drug Administration has extended the action date to March 29, 2010, for its review of the supplemental New Drug Application for NUVIGIL Tablets. The sNDA is for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel.
This sNDA for NUVIGIL was filed with the FDA on June 29, 2009, and given the action date of December 29, 2009, under the Prescription Drug User Fee Act. The company submitted additional information within 90 days of the assigned action date. Subsequently, the FDA informed the company that the agency required more time for a full review of the submission and, therefore, would extend the action date by three months.
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