Natco Pharma gains 9% on USFDA tentative nod for cancer drug

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26 Aug, 2025 12:21

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Moneycontrol BureauShares of Natco Pharma advanced 9.5 percent intraday Friday as it has received tentative approval for Sorafenib tablets from US Food and Drug Administration (USFDA).The company's marketing partner, Mylan Inc., has received a tentative approval for its abbreviated new drug application (ANDA) for Sorafenib Tablets, 200mg, with the USFDA."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," as per company release."Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc., sells Sorafenib Tablets under brand name NEXAVAR in the US market. For the 12 months ending December 31, 2015, NEXAVAR had US sales of approximately USD 300 million," it added.Natco and Mylan have filed an ANDA containing a paragraph IV certification for this product. The company manufactures this product at its facility in Kothur, Telangana, India.At 14:18 hrs Natco Pharma was quoting at Rs 505, up Rs 27.45, or 5.75 percent on the BSE.Posted by Rakesh Patil