Natco Pharma's US partner Mylan files application with USFDA

According to the marketing partner, they are the first to have filed a substantially complete ANDA containing a Paragraph IV certification for this product

Drug firm Natco Pharma's marketing partner Mylan Inc has filed an application with the US health regulator for generic Sorafenib tablets used mainly for treatment of liver and kidney cancers.

The company's marketing partner Mylan Inc has filed an abbreviated new drug application (ANDA) for Sorafenib tablets in the strength of 200mg with the US Food and Drug Administration (USFDA), Natco Pharma said in a filing to the BSE today.

This product is the generic version of Nexavar, indicated for the treatment of certain types of cancers including unresectable hepatocellular carcinoma and advanced renal cell carcinoma, it added.

"Natco and its marketing partner believe that they are the first to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval," Natco Pharma said.

Currently, Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc and Onyx Pharmaceuticals Inc sell the product under Nexavar brand name in US market, it added.

"For the 12 months ending Dec 31, 2014, Nexavar had US sales of approximately USD 48 million, according to IMS Health," Natco Pharma said.

Shares of Natco Pharma today closed at Rs 1,431.70 on the BSE, down 0.17 per cent from the previous close.