Natco Pharma, one of the few Indian companies to venture into new drug discovery research, announced that its marketing partner in the USA, Breckenridge Pharmaceutical has received a tentative approval from the United States Food & Drug Administration (USFDA) for Armodafinil 50mg, 150mg and 250mg tablets.

Breckenridge filed Abbreviated New Drug Application (ANDA) with a Paragraph IV certification to obtain approval to engage in the commercial manufacture, use and sale of its generic to Nuvigil prior to expiration of the listed patents. Natco and Breckenridge have entered into a settlement regarding the ANDA with Cephalon, the terms of which are confidential.

Cephalon has granted Natco and Breckenridge a license to market generic version of the 500mg, 100mg, 150mg, 200mg and 250mg strengths of Nuvigil beginning 180 days after the initial launch of these strengths.

Shares of the company gained Rs 47.2, or 3.74%, to trade at Rs 1,308.80. The total volume of shares traded was 2,771 at the BSE (12.12 p.m., Tuesday).