Natco's US partner gets FDA approval for wakefulness tablets
Breckenridge Pharmaceutical Inc, has received a tentative approval from the US health regulator for its generic Armodafinil tablets
New Delhi, October 21, 2014: Natco Pharma's marketing partner in the US, Breckenridge Pharmaceutical Inc, has received a tentative approval from the US health regulator for its generic Armodafinil tablets. These tablets are used for improving wakefulness in adults. Natco Pharma said in a filing to BSE that 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.
The company also said that the US company has filed the ANDA with a paragraph IV certification to obtain approval to manufacture, use and sale of its generic Nuvigil tablets prior to the expiry of the listed tablets.
"Currently Cephalon (acquired by Teva in 2011) sells Armodafinil 50mg, 150mg, and 250mg tablets under the brand name Nuvigil in the US market," said Natco Pharma.