Zydus Cadila receives USFDA approval for Simvastatin Tab
The drug, a lipid lowering agent falls in the cardiovascular segment.
Tweet-- Zydus Cadila has launched Simvastatin Tablets 5 mg, 10 mg, 20 mg, 40 mg and 80 mg., in the US market on the very first day of receiving the approvals from the US FDA.
The drug, a lipid lowering agent falls in the cardiovascular segment. The branded sales of Simvastatin Tablets in the US market was 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 42 ANDAs and 45 DMFs.