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Natco Pharma has said that its marketing partner Mylan Inc has got tentative approval from the US health regulator for selling generic Sorafenib tablets that are used in the treatment of cancer in the American market.
Natco Pharma has said in a BSE filing that the company’s marketing partner Mylan Inc has received a tentative approval from the United States Food and Drug Administration (USFDA) for abbreviated new drug applicable (ANDA) for Sorafenib tablets in the strength of 200 mg.
It further said that “Natco and Mylan have filed an ANDA containing a Paragraph IV certification for this product.”
