Hyderabad: Natco Pharma’s Abbreviated New Drug Application (ANDA) for generic version of Armodafinil tablets has been approved by the US Food and Drug Administration.
Announcing receipt of the final approval for its ANDA, which contained a paragraph IV certification, a release from the company on Tuesday said Natco and its marketing partner Breckenridge Pharmaceutical plan to launch the product in the US market immediately. Cephalon, which Teva acquired in 2011, sells Armodafinil tablets under the brand name of Nuvugil in the US. A wakefulness promoting agent for oral administration, Nuvugil had US sales of around $480 million during the 12 months ended December 2015, the release said.
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