Otsuka TV and banner ads for Rexulti draw rebuke from FDA watchdog
Otsuka is the latest pharma in a week to receive a violation letter from FDA’s drug promotion police. Its Rexulti TV commercial and a banner ad cross the line and contain “false or misleading” efficacy claims, the agency’s Office of Prescription Drug Promotion said in the untitled letter.
Both ads contain claims that adding Rexulti to antidepressant treatment was proven to reduce depression symptoms by 62%. However, FDA’s OPDP says that overstates what was shown in Otsuka’s studies.
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