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Otsuka Busulfex's Overall Survival Claim Does Not Survive CDER Advertising Scrutiny

This article was originally published in The Pink Sheet Daily

Executive Summary

Statistical analyses based on pivotal trial data and used to promote a drug must prove what they purport to prove, FDA's Office of Prescription Drug Promotion says in an NOV letter to Otsuka over a website for the leukemia drug Busulfex (busulfan).

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