The drug, a lipid-lowering agent which helps to prevent a stroke or heart attack, falls in the cardiovascular segment of the market, the company noted. Cadila said it would market the drug through its subsidiary Zydus Pharmaceuticals.
The branded sales of simvastatin (marketed as Zocor by Merck & Co.) in the US, was estimated at $4.6 billion.
This marks the 18th approval of a new drug application for Cadila since the commencement of filing process in FY 2003-04.