Express Pharma

Natco Pharma seeks US FDA approval for hepatitis drug

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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 exclusivity upon receiving final FDA approval.”

Natco Pharma has filed an abbreviated new drug application (ANDA) for Sofosbuvir Tablets, 400mg, with the United States Food and Drug Administration (US FDA). Sofosbuvir is used for chronic hepatitis C infection and sold globally by Gilead Sciences, Inc, under its brand Sovaldi, Natco Pharma said in a filing to BSE.

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 exclusivity upon receiving final FDA approval,” it added. For the 12 months ending December 31, 2017, Sovaldi had US sales of approximately $130 million as per Gilead Sciences’ unaudited results released for the year ending December 31, 2017, Natco Pharma said.

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