Aurobindo Pharma gets FDA nod for rosuvastatin calcium tabs
New Delhi : Aurobindo Pharma has received final approval from the US health regulator USFDA for rosuvastatin calcium tablets, used in lowering cholesterol.
"The company has received final approval by the US Food and Drug Administration (USFDA) for Rosuvastatin Calcium tablets," Aurobindo Pharma said in a BSE filing.
It further said: "Aurobindo was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification, therefore, Aurobindo is eligible for 180 days of generic drug shared exclusivity. The product is launched in the US market."
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, Aurobindo Pharma said Rosuvastatin calcium tablets achieved annual sales of around USD 6.78 billion.
Aurobindo Pharma currently has a total of 274 ANDA approvals (234 final approvals including 13 from Aurolife Pharma LLC and 40 tentative approvals) from the US.
Stock of Aurobindo Pharma was trading 3.87 per cent higher at Rs 788.65 in the morning trade on BSE.