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Natco Pharma gets USFDA nod for Armodafinil tablets

Press Trust of India  |  New Delhi 

Drug firm has received the final approval from the US health regulator for generic Armodafinil tablets, used as wakefulness promoting agent, and plans to launch the product immediately in the US.

The company has received final approval from the US Food and Drug Administration (USFDA) for generic version of Armodafinil tablets in the strengths of 50 mg, 150 mg and 250 mg, said in a filing to


The company's abbreviated new drug application (ANDA) contains a paragraph IV certification, it added.

"Natco and its marketing partner Breckenridge Pharmaceutical Inc plan to launch this product in market immediately," said.

Cephalon sells the product in three strengths under the brand name 'Nuvugil', it added.

According to IMS health, Nuvugil tablets had US sales of around USD 480 million for twelve months ending December 2015, said.

Nuvugil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy, or shift work disorder.

Shares of were today trading 1.76 per cent down at Rs 601.35 apiece on

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

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