Ximelagatran and Its Risk Management Plan in United States

Abstract

Abstract: The risk management for pharmaceutical products applies toa life cycle ofa new drug development from Investigational New Drug (IND) , New Drug Application (NDA) to post -marketing. It plays a critical role in its withdrawal from the market. In this article we reviewed the risk management events of Ximelagatran(Exanta R) which is a new generation of anti-clotting drug manufactured by AstraZeneca, from its new drug approval to its withdrawal. The experience of Ximelagatran risk management in USA might provide a clue for the future risk manage ment of drug safety in China.

Key words: ximelagatran, drug risk management, risk management plan, FDA

CLC Number:

R954

GUO Jing ,GUO Jian-fei. Ximelagatran and Its Risk Management Plan in United States [J]. Chinese Journal of Pharmacovigilance, 2013, 10(2): 84-87.

References

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