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.
For comments and feedback contact: editorial@rttnews.com
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.