Natco Pharma Limited announced that its marketing partner, Mylan Inc has received a tentative approval for its Abbreviated New Drug Application (ANDA) for Sorafenib Tablets, 200mg, with the U.S. FDA.
This product 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 Mylan have filed an ANDA containing a Paragraph IV certification for this product. NATCO manufactures this product at its facility in Kothur, Mahaboobnagar District, Telangana State, India.
Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc., sells Sorafenib Tablets, 200mg, under Brand name NEXAVAR®, in the U.S. market. For the 12 months ending Dec. 31, 2015, NEXAVAR® had U.S. sales of approximately $300 million.(SOURCE: Bayer’s Annual Report