New Delhi : Jubilant Life Sciences has received approval from the US health regulator to market Rosuvastatin Calcium tablets, used for the treatment of hyperlipidemia, in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) for Rosuvastatin Calcium tablets in strengths of 5 mg, 10 mg, 20 mg, and 40 mg, Jubilant Life Sciences said in a regulatory filing.
Jubilant’s product is the generic version of IPR Pharmaceuticals’ Crestor which is used for the treatment of hyperlipidemia or mixed dyslipidemia.
The company said that it has received seven approvals from the USFDA during the year.
As on September 30, Jubilant had a total of 72 abbreviated new drug applications (ANDAs) for oral solids filed in the US, of which 47 have been approved.
Shares of the company ended at Rs 691.35 apiece on the BSE, up 0.64 per cent from previous close.