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Imposing Everolimus REMS On Sirolimus Rests On If There Is New Safety Info

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The approval of Novartis' Zortress (everolimus) with a Risk Evaluation and Mitigation Strategy has opened up an FDA review of whether Pfizer's Rapamune (sirolimus), from which everolimus is derived, should have a similar plan

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