Lupin receives USFDA approval for generic drug to treat sleep disorders

NEW DELHI: Lupin Pharmaceuticals (LPI), US subsidiary of Indian drug maker Lupin, has received the US Food and Drug Administration's (FDA) approval for its Armodafinil tablets indicated to improve wakefulness in adult patients with obstructive sleep apnea, narcolepsy or shift work disorder. Armodafinil is a generic version of Cephalon Inc's Nuvigil tablets.

LPI will begin to promote the product in the US shortly, the company informed the Bombay Stock Exchange (BSE) in a release on Tuesday evening. US FDA has granted approval for four strengths of the tablet—50mg, 150mg, 200mg and 250 mg.

Nuvigil had US sales of $515.6 million, Lupin said, citing IMS data from September 2016.

Lupin's share prices rose 0.82% on Tuesday to close at Rs1,517.05 on BSE, where the benchmark Sensex ended 0.17% higher.