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FDA Issues Letter to Sunovion Pharmaceuticals, Claims Patient Brochures Made by Company to Support Its Respiratory Drug Brovana Mislead, Parker Waichman LLP Notes
Date:11/1/2013

New York, New York (PRWEB) November 01, 2013

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and medical devices, is noting that the U.S. Food and Drug Administration (FDA) has made allegations in a letter sent to Sunovion Pharmaceuticals on Oct. 24, 2013, that patient brochures made by the drug maker to support its respiratory drug Brovana are misleading in that they overstate the drug’s efficacy, make unsubstantiated claims, and minimize risks associated with the drug.

The FDA also alleges in its letter to Sunovion that the drug maker was promoting Brovana in a deceptive manner by downplaying references to the drug’s risks, which include a black-box warning of potential fatalities for some asthma patients, while highlighting in big, bold fonts the drug’s benefits. The brochures, the FDA letter further notes, also exaggerate the drug’s effectiveness by claiming it could help patients “resume their baseline activities of daily living.” Such claims were precluded by results of clinical studies, the letter notes, which found that Brovana produced an improvement of about 10 percent in the volume of air that patients can exhale during a forced breath.

“Drug makers need to be especially diligent when producing promotional material for the general public; keeping people informed with the best available information is always the proper solution,” says Gary Falkowitz, Managing Attorney at Parker Waichman LLP. “The FDA is doing exactly what they are supposed to. In
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