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Lupin gets USFDA nod for generic Armodafinil tablets

Press Trust of India  |  New Delhi 

Drug major today said it has received approval from the US health regulator to market its Armodafinil tablets, indicated to improve wakefulness, in the American market.

The company's US-based subsidiary Pharmaceuticals, Inc (LPI) has received final approval for Armodafinil tablets in strengths of 50 mg, 150 mg, 200 mg and 250 mg from the United States Food and Drug Administration (FDA), Ltd said in a statement.

The company's product is a generic version of Cephalon, Inc's Nuvigil tablets which is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy or shift work disorder (SWD).

"LPI shall commence promoting the product in the US shortly," the Mumbai-based company said.

This is the second approval that Lupin has received in the last six days from its manufacturing facility. The company had earlier received a tentative approval for Generic Epzicom tablets.

Last month the USFDA had cleared Lupin's plant of violations of good manufacturing practices (cGMP) observed during an inspection in March 2016.

As per IMS sales data, Nuvigil tablets had US sales of USD 515.6 million.

Lupin shares today ended 0.82 per cent up at Rs 1,517.05 apiece on BSE.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Tue, November 29 2016. 20:32 IST