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Natco Pharma has filed an abbreviated new drug application (ANDA) for Sofosbuvir Tablets, 400mg, with the United States Food and Drug Administration (USFDA).
The company in a filing to BSE stated that, Sofosbuvir is used for chronic hepatitis C infection and is sold globally by Gilead Sciences, Inc, under its brand Sovaldi.
Further it added that, the company believes 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 exclusively upon receiving final FDA approval.”
