Physician Communication That Combined Results Of Unrelated Studies Gets Rebuke From US FDA
Althera’s misleading claims about its cholesterol drug Roszet is based on a ‘scientifically unsound analysis,’ OPDP tells company. FDA says studies cited in the pamphlet for doctors do not support claims regarding the magnitude of treatment effect.
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ViiV Wants FDA, Not NAD, To Handle Dispute Over Its Dovato HIV Drug Ads
National Advertising Division refers Gilead’s challenge of ViiV’s advertisements to the FDA and FTC after ViiV declines to participate in its review. Gilead says the ads claim Dovato is superior to its HIV drug Biktarvy, while ViiV suggests a review would amount to second-guessing the FDA.
Bausch’s Duobrii Promos Censured For Excluding Risk Info, Making Misleading Superiority Claims
Bausch gets an untitled letter from the US FDA criticizing a video and webpage promoting its psoriasis lotion. The agency also objects to superiority efficacy claims based on post hoc analyses of a single phase II trial after expressing similar concerns to the company two years ago.
CytoDyn’s Promotion Of Investigational Drug Leronlimab Once Again Rebuked By US FDA
OPDP warning letter objects to video interview in which CytoDyn's then CEO touts use of the investigational drug for COVID-19. The exec says he is ‘making up numbers’ but if the pattern continues there will be ‘the most fantastic results’ anybody could ever imagine.