The US Food and Drug Administration (FDA) has granted its final approval for Lupin
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
tablet, in the US shortly.
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.