Sandoz Approved to Launch Crestor, a Generic Statin, in China

Sandoz, the generic drug arm of Novartis, was approved to market the statin Crestor (rosuvastatin) in China using the NMPA's new Quality Consistency Evaluation rules. The QCE rules require a company to prove bioequivalence to international standard drugs, instead of national standard drugs. China has declared all drugs approved after 2007 will have to comply with the QCE rules or lose their marketing licenses. The Crestor approval was the first OCE completed by a multinational pharma, Sandoz said. The company vowed to submit other generics for China approvals. More details....

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