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Japan Approves Astellas Transplant Drug Delayed In U.S.

This article was originally published in PharmAsia News

Executive Summary

Astellas Pharma said it has won approval to market its Graceptor (tacrolimus) transplant drug in Japan. The new version is a once-daily form of Astellas' twice-daily Prograf, a $2 billion-a-year seller for the company, but one that lost its U.S. patent protection earlier this year. The U.S. FDA has yet to approve tacrolimus as a treatment for kidney and liver transplants, issuing "approvable" letters on the grounds Astellas submitted insufficient data. The U.S. agency also has declined approval for a heart transplant indication, issuing a "non approvable" letter. Tacrolimus already is approved in Europe, where it is marketed as Advagraf. (Click here for more

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