Lupin subsidiary receives USFDA approval for generic Nuvigil Tablets

30 Nov 2016 Evaluate

Lupin’s US subsidiary - Lupin Pharmaceuticals, Inc., 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 (USFDA) to market a generic version of Cephalon, Inc.’s Nuvigil Tablets 50 mg, 150 mg, 200 mg and 250 mg. The company shall commence promoting the product in the US shortly. Nuvigil Tablets had US sales of $515.6 million, as per IMS MAT September 2016.

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).

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.



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