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Astellas To Take U.S. FDA To Court For Allowing Generic Of Prograf

This article was originally published in PharmAsia News

Executive Summary

Astellas Pharma says it plans to file a citizen petition against U.S. FDA over its decision to allow the marketing of a generic of the Astellas drug Prograf (tacrolimus) for preventing organ-transplant rejections. The issue centers on patent protection for the drug, which Astellas lost more than a year ago, and FDA's refusal to require generics to conduct their own clinical trials to compare the absorption of their versions with Prograf. Astellas said it also intends to demand labels on the generics to advise that physicians be notified when a pharmacist substitutes a generic for the branded drug. (Click here for more
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