Lupin receives US FDA nod for sleep disorder drug armodafinil

The US Food and Drug Administration (FDA) has granted its final approval for Lupin Ltd’s armodafinil tablet (in strengthens of 50 mg, 150 mg, 200 mg and 250 mg), which is used for treating sleep disorder. The company had filed the application for the new drug from its Goa manufacturing facility.

The company’s US subsidiary Lupin Pharmaceuticals Inc is expected to commence promotion of this approved product, a generic version of Cephalon Inc’s Nuvigil tablet, in the US shortly. 

Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy or shift work disorder (SWD). Nuvigil tablet had US sales of $ 515.6 million, according to IMS MAT September 2016.