Cephalon reveals extended action date for NUVIGIL tablets

Cephalon revealed this week that the Food and Drug Administration (FDA) has extended the action date the review of its supplemental new drug application for NUVIGIL (armodafinil) tablets.

The FDA will now examine the submission – which regards the treatment of fatigue brought about by jet lag – before the new date of March 29th 2010.

According to the firm, the application was filed on June 29th 2009 and an action date of December 29th 2009 was issued by the FDA.

Dr Lesley Russell, chief medical officer at Cephalon, said: “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.”

In November, Cephalon and Ception announced that a study into the drug CINQUIL (reslizumab) – which the firms have been collaborating on – yielded a positive outcome.