FDA Chides Sunovion Over Misstating Brovana Risks, Benefits
By Jeff Overley (October 30, 2013, 4:50 PM EDT) -- Sunovion Pharmaceuticals Inc. promoted its respiratory drug Brovana in a deceptive manner that buried discussion of risks in fine print and exaggerated effectiveness by suggesting the product would completely revitalize patients, the U.S. Food and Drug Administration charged in a letter released Tuesday.
FDA took issue with several statements in Sunovion's promotional brochures, including an assertion that Brovana, which treats chronic obstructive pulmonary disease, might help patients "get back to daily living."
According to FDA, clinical trials found that Brovana produced a roughly 10 percent improvement in the volume of air patients can exhale during a forced breath. Although that is...
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