Sun Pharma gets US FDA nod for Riluzole 50mg tablets
Riluzole is used to treat amyotrophic lateral sclerosis. Sun Pharma had received tentative approval for the drug from US FDA in 2010.
June 22, 2013 / 12:17 IST
Moneycontrol Bureau
The US Food and Drugs Administration (FDA) has approved Sun Pharmaceuticals' abbreviated new drug application (ANDA) for a generic version of Riluzole in 50 mg strength, according to the drug regulator's website.The company had earlier received tentative approval for the drug from the US FDA in 2010.Riluzole is a generic version of Sanofi Aventis' Rilutek. Sanofi sold US rights for Rilutek and a few other drugs to Covis Pharma earlier this year.Sun Pharma's Indian rival Glenmark had also announced earlier this week that its US generics arm received FDA approval for Riluzole in 50 mg strength, indicated for the treatment of amyotrophic lateral sclerosis.Riluzole had sales of USD 64 million for the year ended March 2013, Glenmark had said.Apotex Corp and Impax Labs are the two other firms, that have also got US FDA approval to sell the drug.Sun Pharma shares were down 1.9 percent at Rs 951 on NSE in afternoon trade on Friday. Discover the latest Business News, Sensex, and Nifty updates. Obtain Personal Finance insights, tax queries, and expert opinions on Moneycontrol or download the Moneycontrol App to stay updated!
