Natco Pharma Limited, through its marketing partner Mylan Inc, has filed an abbreviated new drug application (ANDA) for sorafenib tablets, 200mg, with the US Food and Drug Administration (USFDA). Sorafenib is the generic version of Nexavar, which is indicated for the treatment of certain types of cancers including unresectable hepatocellular carcinoma and advanced renal cell carcinoma.
“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,” said Natco in a press release.
Nexavar tablets - marketed by Bayer Healthcare, Bayer Healthcare Pharmaceuticals and Onyx Pharmaceuticals – had recorded sales of approximately $48 million for the 12 months ending December 31, 2014 in the US, according to IMS Health.
“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,” said Natco in a press release.
Nexavar tablets - marketed by Bayer Healthcare, Bayer Healthcare Pharmaceuticals and Onyx Pharmaceuticals – had recorded sales of approximately $48 million for the 12 months ending December 31, 2014 in the US, according to IMS Health.