Lupin Pharmaceuticals, Inc. has received final approval from the FDA to market a generic version of Cephalon, Inc.’s Nuvigil tablets.

Lupin Limited announced that its U.S. subsidiary Lupin Pharmaceuticals, Inc. (LPI) has received final approval for its Armodafinil tablets 50 mg, 150 mg, 200 mg and 250 mg from the United States Food and Drug Administration (FDA) to market a generic version of Cephalon, Inc.’s Nuvigil tablets 50 mg, 150 mg, 200 mg and 250 mg. LPI shall commence promoting the product in the U.S. shortly.

Lupin’s Armodafinil tablets 50 mg, 150 mg, 200 mg and 250 mg are the AB rated generic equivalents of Cephalon, Inc.’s Nuvigil tablets 50 mg, 150 mg, 200 mg and 250 mg. 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 tablets had U.S. sales of $515.6 million (IMS MAT September 2016).

Lupin is a transnational pharmaceutical company developing and delivering a wide range of branded and generic formulations, biotechnology products and APIs globally. The company is a significant player in the cardiovascular, diabetology, asthma, pediatric, CNS, GI, anti-infective and NSAID space and holds a global position in the anti-TB segment.

(Source: Business Wire)