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

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).

Parker Waichman LLP
Gary P. Falkowitz, Managing Attorney
1+ (800) LAW-INFO
1+ (800) 529-4636

Read the full story at

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. UCSF chancellor issues call-to-arms to patient advocates
2. Radiologists rank themselves as less than competent on health policy issues
3. Genetic abnormalities in benign or malignant tissues predict relapse of prostate cancer
4. FDA Issues Multiple Sclerosis Drug Alert
5. Quality of care, other issues may cause worse results in black prostate cancer surgery patients
6. U.S. Task Force Issues Blood Pressure Guidelines
7. Internists in Washington to discuss patient and professional issues in meetings on Capitol Hill
8. Cheaper drug could lead to serious eye issues
9. Insulite Labs announces the launch of the PCOS Inspiration Hour, a one hour virtual gathering place for women with PCOS and other women’s health issues to come together.
10. Issues Report on Prostate Health Claim Lawsuits and Propecia Side Effect Litigation
11. What Men Should Know About Veins: Varicose Veins and Venous Disease are Real Medical Issues
Post Your Comments:
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... Austin ... of the American College of Mohs Surgery and to Dr. Russell Peckham for medical ... and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency ... named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. ... Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van ... Wellness at Work award to iHire in recognition of their exemplary accomplishments in worksite ... 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum ...
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... To deal with these feelings, many turn to unhealthy avenues, such as drug or ... Center of Marne, Michigan, has released tools for healthy coping following a traumatic event. ...
(Date:6/24/2016)... ... 24, 2016 , ... The Pulmonary Hypertension Association (PHA) learned ... receive two significant new grants to support its work to advance research and ... by recognizing patients, medical professionals and scientists for their work in fighting pulmonary ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... Mass. and SAN CLEMENTE, Calif. , ... California -based mobile pulmonary function testing company, is now able ... PFT devices developed by ndd Medical Technologies , Inc. ... testing done in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® ... , can get any needed testing done in the comfort ...
(Date:6/24/2016)... , June 24, 2016 VolitionRx ... of Dr. Edward Futcher to the ... effective June 23, 2016.Dr. Futcher was also appointed ... Governance Committees.  As a non-executive member of the ... and strategic counsel to VolitionRx in connection with ...
(Date:6/23/2016)... , June 23, 2016 Any dentist who ... challenges of the current process. Many of them do not ... the technical difficulties and high laboratory costs involved. And those ... offer it at such a high cost that the majority ... Dr. Parsa Zadeh , founder of Dental ...
Breaking Medicine Technology: