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FDA NEWS RELEASE

For Immediate Release: July 23, 2012
Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Tudorza Pressair to treat chronic obstructive pulmonary disease

The U.S. Food and Drug Administration today approved Tudorza Pressair (aclidinium bromide) for the long-term maintenance treatment of bronchospasm (narrowing of the airways in the lung) associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

COPD is a serious lung disease that makes breathing difficult. Cigarette smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute. COPD is the fourth leading cause of death in the United States. Symptoms can include chest tightness, chronic cough, and excessive phlegm.

Tudorza Pressair, a dry powder inhaler used twice daily, is a long-acting antimuscarinic agent that helps muscles around the large airways of the lungs stay relaxed to improve airflow.

“COPD is a serious disease that gets worse over time,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in FDA’s Center for Drug Evaluation and Research. “The availability of long-term maintenance drugs for COPD provides additional treatment options for the millions of people who suffer with this debilitating disease.”

The safety and efficacy of Tudorza Pressair were demonstrated in three randomized, placebo-controlled confirmatory clinical trials that included 1,276 patients ages 40 and older with a clinical diagnosis of COPD. Those treated had a smoking history of at least one pack a day for 10 years.

Tudorza Pressair may cause serious side effects, including paradoxical bronchospasm, new or worsened increased pressure in the eyes (acute narrow-angle glaucoma), or new or worsened urinary retention. Tudorza Pressair should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm) and is not recommended for people younger than 18 years. The most common side effects reported by patients using Tudorza Pressair include headache, inflammation of the nasal passage (nasopharyngitis), and cough. 

Tudorza Pressair is distributed by St. Louis-based Forest Pharmaceuticals, a subsidiary of Forest Laboratories.

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 

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