The US Food and Drug Administration (FDA) extended the action date for its review of the supplemental New Drug Application (sNDA) for NUVIGIL (armodafinil) Tablets [C-IV] to March 29, 2010, according to the drug maker Cephalon Inc, Frazer, Pa. The sNDA is for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel.
“We will continue to work closely with the FDA to assist them in completing their review of our application in a timely manner and do not anticipate any further delays beyond the March 29, 2010, action date,” said Lesley Russell, MBChB, MRCP, chief medical officer at Cephalon.
Cephalon filed the sNDA for NUVIGIL on June 29, 2009. The company was given the action date of December 29, 2009, under the Prescription Drug User Fee Act. Cephalon 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 3 months.
NUVIGIL is currently indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work disorder, or narcolepsy.