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Natco Pharma gets US FDA approval for generic Armodafinil tabs


There are plans to launch the product immediately in the US

Drug firm Natco Pharma 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 (US FDA) for generic version of Armodafinil tablets in the strengths of 50 mg, 150 mg and 250 mg, Natco Pharma said in a filing to BSE.

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

“Natco and its marketing partner Breckenridge Pharmaceutical plan to launch this product in USA market immediately,” Natco Pharma 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, Natco Pharma said.

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


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