The FDA has extended the action date for its review of Cephalon’s supplemental New Drug Application (sNDA) for Nuvigil (armodafinil) tablets [C-IV], to March 29, 2010. The sNDA is for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel.
Nuvigil, an isomer of modafinil, was launched in the US in June 2009. It is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy.
The 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 (PDUFA). The company has submitted additional information within 90 days of the assigned action date.
Reportedly, FDA has informed the company that the agency requires more time for a full review of the submission and, therefore, would extend the action date by three months.
Lesley Russell, chief medical officer at Cephalon, said: “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. We remain excited about this opportunity as there are no medications approved by the FDA to treat excessive sleepiness associated with eastbound jet lag disorder.”