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
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