Zydus Cadila gets USFDA nod for cardio drug

Zydus Cadila has received tentative approval from the USFDA to market pravastatin sodium tablets in the following forms: 10mg, 20mg, 40mg and 80mg, in the USA.

According to an official release issued today, the drug, a lipid-lowering agent falls in the cardiovascular segment. The branded sales of pravastatin sodium tablets in the US market was estimated at $1.8 bn in 2005 as per NDC. The company will market the drug through its US subsidiary Zydus Pharmaceuticals (USA), following patent expiry.

This marks the 15th ANDA approval for the group since the start of filing process in FY04. So far, the group has filed 36 ANDAs and 40 DMFs.