Lupin Receives FDA Approval for Generic Nuvigil Tablets

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Mumbai, November 30
Pharma Major Lupin Limited today said that its US subsidiary Lupin Pharmaceuticals, Inc. (LPI) 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. LPI shall commence promoting the product in the US shortly.
Lupin’s Armodafinil Tablets 50 mg, 150 mg, 200 mg and 250 mg are the AB rated generic equivalents of Cephalon, Inc’s Nuvigil Tablets 50 mg, 150 mg, 200 mg and 250 mg.
Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy or shift work disorder (SWD). Nuvigil Tablets had US sales of USD 515.6 million (IMS MAT September 2016).

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