Indian drugmaker Zydus Cadila has received tentative approval from the U.S. FDA to market pravastatin sodium tablets in the U.S. market, the company reported. The drug is a lipid-lowering agent.
The sale of pravastatin sodium tablets in the U.S. was estimated at $1.8 billion in 2005. The company will market the drug through its U.S. subsidiary, Zydus Pharmaceuticals, following patent expiry.
This marks the 15th abbreviated new drug application (ANDA) approval for the group since the beginning of the filing process in 2003. So far, the group has filed 36 ANDAs.