FDA approves Lupin’s Nuvigil generic

SILVER SPRING, Md. — The Food and Drug Administration has approved Lupin Pharmaceuticals’ generic of Nuvigil (armodafinil), the company announced Tuesday. The drug is indicated to improve wakefulness in adults with excessive sleepiness associated with obstructive sleep apnea, narcolepsy or shift work disorder. 

 

Lupin’s generic will be available in 50-, 150-, 200- and 250-mg dosage strengths. The drug has U.S. sales of $515.6 million for the 12 months ended September 2016, according to QuintilesIMS data.