Lupin got FDA approval for Armodafinil Tablets

Nuvigil® tablets had sales of $515.6 mn in the US market.

The Dollar Business Bureau

Lupin Limited (Lupin), a transnational pharma company, announced on Wednesday that its US-based subsidiary Lupin Pharmaceuticals, Inc (LPI) has got the final approval from FDA for its Armodafinil Tablets, used in treatment of obstructive sleep apnea.

“Company’s US subsidiary Lupin Pharmaceuticals, Inc 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,” Lupin said in a release.

LPI shall start promoting the products in the US market shortly, it added.

The pharma major’s Armodafinil tablets in 250 mg, 200 mg, 150 mg and 50 mg are the AB-rated generic equivalents to Nuvigil® tablets of Cephalon, Inc.

The Armodafinil tablets are designated to improve wakefulness in patients having problem of excessive sleepiness related with obstructive sleep apnea (OSA), shift work disorder (SWD) or narcolepsy.

Nuvigil® tablets had sales of $515.6 million in the US market, as per the IMS MAT September 2016.

The Dollar Business Bureau - Nov 30, 2016 12:00 IST