Zydus Cadila has received tentative approval from the US FDA to market Pravastatin Sodium tablets, 10 mg, 20 mg, 40 mg and 80 mg., in the US market. The drug, a lipid lowering agent falls in the cardiovascular segment.
As per NDC, the branded sale of Pravastatin Sodium tablets in the US market was estimated at USD 1.8 bn in 2005. The company will market the drug through its US subsidiary Zydus Pharmaceuticals (USA) Inc., following patent expiry, a company release said.
This marks the 15th ANDA approval for the group since the commencement of filing process in FY 2003-04. So far, the group has filed 36 ANDAs and 40 DMFs.