Clinical

Lupin Receives Tentative FDA Approvals for Generic Nuvigil Tablets

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Lupin Pharmaceuticals Inc (LPI) has received tentative approval for its Armodafinil Tablets, 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg strengths, from the United States Food and Drug Administration (FDA).

Lupin’s Armodafinil Tablets are the AB-rated generic equivalent of Cephalon Inc’s Nuvigil tablets 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg strengths. Armodafinil Tablet is indicated to improve wakefulness in adult patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), narcolepsy, or shift work disorder.

Nuvigil tablets, 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg, had US sales of approximately $420 million, for the 12 months ending March 2013.