Otsuka Busulfex's Overall Survival Claim Does Not Survive CDER Advertising Scrutiny
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).
Learn what's happening at the US FDA. On the go.
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Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
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