Zydus Cadila has received tentative approval from the US FDA to market simvastatin tablets, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg., in the US market. The drug, a lipid lowering agent falls in the cardiovascular segment, a company release said.
The branded sales of simvastatin tablets in the US market were estimated at USD 4.6 bn as per IMS (March 2006). The company will market the drug through its US subsidiary Zydus Pharmaceuticals (USA) Inc.
This marks the 18th ANDA approval for the group since the commencement of filing process in FY 2003-04. So far, the group has filed 41 ANDAs and 45 DMFs.