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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