FDA approves Armodafinil Tablets in U.S.
Armodafinil Tablets are the generic version of Cephalon’s Nuvigil Tablets, which Lupin has been approved to market in the U.S.
The doses for Armodafinil Tablets that have been approved by the FDA are 50 mg, 150 mg, 200 mg and 250 mg. LPI plans to begin the promotion of its newly approved drug in the U.S. in the very near future. The medication is designed to improve wakefulness in adult patients who suffer from excessive sleepiness that is linked to obstructive sleep apnea, narcolepsy or swift work disorder.
As of September, U.S. sales for Nuvigil Tablets, Armodafinil Tablet’s name brand counterpart, are $515.6 million.