Zydus Pharma gets tentative USFDA nod for Simvastatin Tabs

New Delhi, Nov 7 (UNI) Cadila Healthcare Ltd today said it has received tentative approval from the USFDA to market Simvastatin Tablets in the US market.

The company will market the drug through its US subsidiary Zydus Pharmaceuticals (USA) Inc, it said in a statement.

The drug, a lipid lowering agent, falls in the cardiovascular segment and will be available in 5 mg, 10 mg, 20 mg, 40 mg and 80mg.

The branded sales of Simvastatin Tablets in the US market are estimated at 4.6 billion dollars, as per IMS on March 2006.

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.

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