FDA Issues Letter to Sunovion Pharmaceuticals, Claims Patient Brochures Made by Company to Support Its Respiratory Drug Brovana Mislead, Parker Waichman LLP Notes

The U.S. Food and Drug Administration (FDA) charges in a letter sent to Sunovion Pharmaceuticals that patient brochures made by the drug maker to support the company’s respiratory drug Brovana are misleading for several reasons, a key one being that they overstate the drug’s efficacy, notes Parker Waichman LLP.

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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.

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 view of that fact, we believe it is only appropriate for us to look at what is going on here a little more deeply.”

Parker Waichman is currently evaluating cases to determine whether a class action lawsuit is appropriate.

Marlborough, Mass.-based Sunovion Pharmaceuticals Inc., a unit of Osaka, Japan-based Dainippon Sumitomo Pharma Co. Ltd., received approval for its respiratory drug Brovana (generic name: arformoterol tartrate) by the FDA on Oct. 6, 2006, as noted on the FDA’s website, last updated on Feb. 19, 2012. Described as an “inhalation solution,” Brovana was approved for the treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, the FDA’s letter to Sunovion notes. Meant for long-term, twice daily (mornings and evenings) use, the drug is taken via a nebulizer only, says the letter.

If you or a loved one took the prescription drug Brovana, you may have valuable legal rights. To find out more about joining a Brovana class action lawsuit, please visit our website or contact one of our experienced class action lawyers today at 1(800)-LAW-INFO (1-800-529-4636).

Contact:
Parker Waichman LLP
Gary P. Falkowitz, Managing Attorney
1+ (800) LAW-INFO
1+ (800) 529-4636
http://www.yourlawyer.com


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