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China’s State FDA Responds To Cardiotonic Pill Incident

This article was originally published in PharmAsia News

Executive Summary

China's State FDA has made an official response to the report on Cardiotonic Pill side effects (PharmAsia News, Feb. 9, 2009). Zhang Wei, director general of SFDA's Department of Drug Registration, stated that Cardiotonic Pill is registered as a modified dosage form of Salvia miltiorrhiza tablet. Both the dosage change for the generic drug and the brand drug have been studied by designated research institutes according to the requirements of the registration application. Cardiotonic Pill registration review shows that toxicity testing has been conducted in various phases over different periods, especially since the drug has applied for R&D experiments in the U.S. SFDA said that public release of the National Center for ADR Monitoring will be the most authoritative evaluation for adverse drug reactions. (Click here for more - Chinese language)
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