Zydus Cadila receives tentative FDA approval for Pravastatin Sodium Tablets

By Lisa Kerner

Charlotte, N.C., June 15 - Zydus Cadila Healthcare Ltd. said it has received tentative approval from the Food and Drug Administration to market the lipid lowering agent Pravastatin Sodium Tablets (10 mg, 20 mg, 40 mg and 80 mg) in the United States.

The branded sales of Pravastatin Sodium Tablets in the U.S. market were about $1.8 billion in 2005.

The company will market the drug through Zydus Pharmaceuticals (USA) Inc., its U.S. subsidiary.

Zydus Cadila is a pharmaceutical company based in India.

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