Natco Pharma’s US partner gets FDA nod for wakefulness tablets
NEW DELHI: Natco Pharma’s marketing partner in US, Breckenridge Pharmaceutical Inc, has received a tentative approval from the US health regulator for its generic Armodafinil tablets used for improving wakefulness in adults.
Breckenridge Pharmaceutical Inc has received tentative approval from the United States Food and Drug Administration (USFDA) for Armodafinil tablets in the strengths of 50mg, 150mg, and 250mg, Natco PharmaBSE -4.05 % said in a filing to the BSE.
Breckenridge had filed its abbreviated new drug application (ANDA) with a Paragraph IV certification to obtain approval to manufacture, use and sale of its generic Nuvigil tablets prior to expiry of the listed patents, it added.
“Currently Cephalon (acquired by Teva in 2011) sells Armodafinil 50mg, 150mg, and 250mg tablets under the brand name Nuvigil in the US market,” Natco Pharma said.
Natco and Breckenridge have entered into a settlement regarding the ANDA with Cephalon, ..