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Natco Pharma seeks USFDA approval for hepatitis drug

Press Trust of India  |  New Delhi 

Drug firm today said it has filed an (ANDA) for Tablets, 400mg, with the (USFDA). is used for and sold globally by Gilead Sciences, Inc, under its brand Sovaldi, said in a filing to BSE. The company believes that "they are the first to have filed a substantially complete 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 USD 130 million as per Gilead Sciences Inc's unaudited results released for the year ending December 31, 2017, said. Shares of were trading at Rs 786.05 per scrip on BSE, down 1.65 per cent from its previous close.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Thu, March 01 2018. 14:00 IST
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