Mylan Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP,100 mg and 200 mg. This product is the generic version of Cephalon’s Provigil Tablets and is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder.
“Mylan is pleased to bring a generic version of Provigil Tablets to the US market prior to the expiration of the first-filer’s 180-day marketing exclusivity period,” said Mylan CEO, Heather Bresch. “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.”
Modafinil Tablets, 100 mg and 200 mg, had US sales of approximately $1.3 billion for the 12 months ending June 30, 2012, according to IMS Health. Mylan is launching this product immediately.