NATCO announces USFDA filing for Sofosbuvir tablets, 400 mg

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced that it has filed an Abbreviated New Drug Application (ANDA) for Sofosbuvir Tablets, 400mg, with the U.S. Federal Drug Administration (USFDA). Sofosbuvir is  a medicine used for chronic hepatitis C infection and sold globally by Gilead Sciences, Inc., under its brand Sovaldi®. Natco 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. For the 12 months ending Dec. 31, 2017, SOVALDI® had U.S. sales of approximately $130 million as per Gilead Sciences Inc. unaudited results released for the year ending 31st December, 2017.

The release as fetched from its publisher. natcopharma.co.in ↗