Risk Info Should Be In Ad, Not Attached Label, FDA Says In Bystolic Ad Letter
Putting product labeling at the end of a journal ad "does not mitigate the misleading omission of risk information in the body of the ad," FDA's ad division concludes in a warning letter for Forest Laboratories'Bystolic (nebivolol)
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With approval of Forest/Mylan's Bystolic (nebivolol) - the newest member of a crowded beta blocker class - the company is gearing up to launch with an experienced sales force, data to differentiate the drug, and a price in line with one of the most commonly used drugs in the class
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.