Natco gets USFDA nod for anti-sleep tablets

Armodafinil treats daytime sleepiness linked to sleep apnea, narcolepsy and shift work disorder; generic equivalent in the US had sales of $480 mn in 2015

Hyderabad-based drug firm Natco Pharma has received final approval from the US Food and Drug Administration (USFDA) for a generic version of Armodafinil tablets used as a wakefulness promoting agent for oral administration.

The USFDA has approved the Abbreviated New Drug Application (ANDA) for Armodafinil tablets, 50 mg, 150 mg and 250 mg.

Natco and its marketing partner Breckenridge Pharmaceutical plan to launch this product in the US market immediately.

Armodafinil is used to treat excessive daytime sleepiness associated with obstructive sleep apnea, narcolepsy, and shift work disorder. It is commonly used off-label to treat attention deficit hyperactivity disorder, chronic fatigue syndrome, and major depressive disorder. It has been shown to improve vigilance in air traffic controllers.

US-based Cephalon, a subsidiary of Teva Pharmaceuticals, sells Armodafinil 50 mg, 150 mg and 250 mg tablets under brand name Nuvugil in the US market. Nuvugil had sales of around $480 million during the year 2015, according to IMS Health data.