Natco gets USFDA tentative nod for generic Tamiflu
Mar 18 2014 , New Delhi
The tentative approval of Oseltamivir Phosphate (Tamiflu) capsules by the US Food and Drug Administration is for multiple strengths of 30mg, 45 mg and 75 mg, the company said in a filing to the BSE.
Natco may have first to file status for the abbreviated new drug application (ANDA), contingent upon successful litigation outcome of original drug patent 5,763,483.
The Hyderabad based company, citing IMS data, said Tamiflu had sales of approximately USD 495 million for the 12 months ending September 2013.
Shares of Natco Pharma were trading at Rs 832 per scrip in the afternoon trade, up 0.96 per cent from the previous close on the BSE.