DDMAC To Cornerstone: Zyflo CR Promotions Need Current Safety Labeling
An FDA advertising violation letter for Cornerstone Therapeutics' asthma therapy Zyflo CR should serve to remind industry that providing outdated safety labeling with promotions is a sure way to draw the agency's regulatory scrutiny
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In separate “notice of violation” letters issued Oct. 31 but posted several days apart, FDA rejected superiority claims on the part of Cornerstone Therapeutics and Ony for their respiratory distress syndrome drugs.
Agency asks physicians to report instances of off-label promotion made during continuing medical education classes.
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