The US Food and Drug Administration (FDA) has granted final approval to Mylan Pharmaceuticals' abbreviated new drug application (ANDA) of Modafinil tablets USP,100 mg and 200 mg.
Modafinil USP,100 mg and 200 mg tablets are generic equivalent to Cephalon's Provigil tablets and are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work disorder.
Mylan CEO Heather Bresch said the company brings a generic version of Provigil tablets to the US market prior to the expiration of the first-filer's 180-day marketing exclusivity period.
"This launch represents Mylan's continued commitment to expanding access to high quality, more affordable medicine, and we are pleased to do our part in helping to meet patients' unmet needs," Bresch added.
