New Delhi : Drug major Sun Pharma has received final approval from the US health regulator USFDA for rosuvastatin calcium tablets, used in lowering cholesterol.
In a BSE filing, Sun Pharma said: “One of its subsidiaries has received final approval from USFDA for its Abbreviated New Drug Application (ANDA) for generic version of Crestor, Rosuvastatin Calcium tablets.
Rosuvastatin calcium tablets are generic version of Crestor tablets of IPR Pharmaceuticals, Inc. Approval has been granted in the strengths of 5 mg, 10 mg, 20 mg and 40 mg.
Crestor is used to lower cholesterol and fats (triglycerides) in the blood and is used to reduce the chances of developing problems such as heart disease and strokes.
Quoting IMS sales data for the 12 months to May 2016, Sun Pharma said Rosuvastatin calcium tablets achieved annual sales of around USD 6.78 billion.
Shares of Sun Pharma were trading 1.38 per cent up, at Rs 793 apiece, in the morning trade on BSE.