FDA Maintains Essential Use Status of Combivent(R) (ipratropium bromide and albuterol sulfate) Inhalation Aerosol Through 2013

COMBIVENT remains on the market and available to chronic obstructive pulmonary disease (COPD) patients

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Boehringer Ingelheim Pharmaceuticals, Inc.

Apr 13, 2010, 09:40 ET

RIDGEFIELD, Conn., April 13 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced that the U.S. Food and Drug Administration (FDA) has determined that the "essential use" status of Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol will be effective through December 31, 2013. With this ruling, COMBIVENT will remain on the market and available to the more than two million chronic obstructive pulmonary disease (COPD) patients who rely on it as a bronchodilator.

As a result of the Montreal Protocol, the U.S. Food and Drug Administration (FDA) is phasing-out all remaining prescription oral pressurized metered dose inhalers (MDIs) that use chlorofluorocarbons (CFCs) by removing the "essential use" designation on these products. The FDA's Final Rule, issued today, determines the timing for this phase-out for the seven remaining MDIs used to treat asthma and COPD.

BIPI has invested more than ten years researching and developing a CFC-free replacement product that will deliver the active ingredients in COMBIVENT and we are committed to working closely with the FDA on its development. The replacement product is in late-stage clinical development and the Company's goal is that this new product will be available to patients prior to the December 31, 2013 effective date to allow ample time for a seamless transition.

"BIPI requested this status be maintained to allow uninterrupted patient care while we develop a chlorofluorocarbon (CFC)-free COMBIVENT product," said Christopher Corsico, M.D., MPH, U.S. medical director, Boehringer Ingelheim Pharmaceuticals, Inc. "As a leader in respiratory care, we are dedicated to providing optimal patient care, and are pleased the FDA ruling will allow continued access to COMBIVENT for patients."

Uninterrupted patient care is important for patients with COPD. This population is particularly vulnerable because nearly 50 percent of patients who use COMBIVENT are 65 or older and 84 percent of patients who use COMBIVENT often have other diseases requiring various treatments to stabilize their health.

About COPD

COPD is a progressive, but preventable and treatable lung condition that is characterized by a restricted flow of air into and out of the lungs and loss of lung function over time. It includes chronic bronchitis, emphysema, or both.

COPD is the fourth-leading cause of death and the second-leading cause of disability in the United States, and is projected to become the third-leading fatal illness by 2020. Each year, COPD kills 120,000 Americans – that's one death every four minutes.

The disease primarily affects current and former smokers and symptoms include shortness of breath, coughing (sometimes with phlegm or mucus) and wheezing. When most severe, COPD may even limit a person's ability to perform simple tasks such as washing and dressing. The damage in the lungs caused by COPD is not reversible, but it is treatable.

About Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol

COMBIVENT Inhalation Aerosol is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

Important Safety Information

COMBIVENT Inhalation Aerosol should not be used in patients who:

Are allergic to soya lecithin or related food products such as soybeans and peanuts
Are allergic to any of the ingredients in COMBIVENT Inhalation Aerosol or to atropine or other similar drugs

COMBIVENT Inhalation Aerosol can cause the narrowing of the airways to get worse (paradoxical bronchospasm) in some patients, which may be life threatening. Stop taking COMBIVENT Inhalation Aerosol and call your doctor or get emergency help if this happens.

COMBIVENT Inhalation Aerosol can cause serious allergic reactions. Symptoms include itching, swelling of the face, lips, tongue, or throat (which may cause difficulty in breathing or swallowing), skin rash, hives, bronchospasm (airway narrowing), or anaphylaxis. Stop taking COMBIVENT Inhalation Aerosol and call your doctor or get emergency help if you get any of these symptoms.

COMBIVENT Inhalation Aerosol can cause serious heart-related side effects, such as an increase in pulse, blood pressure, and/or related symptoms.

Deaths have been reported with similar inhaled medicines in asthma patients who use the medicine too much. Do not use COMBIVENT Inhalation Aerosol more often than your healthcare provider has directed.

Certain medical conditions may increase your risk of side effects.

Tell your healthcare provider about all your conditions and medicines you take, including if you:

Have narrow-angle glaucoma
Have prostate or urinary problems
Have a history of heart disease (e.g., reduced heart circulation, irregular heartbeat, and high blood pressure)
Have seizures
Have a thyroid disorder
Have diabetes
Have low potassium levels
Have kidney disease
Have liver disease
Are pregnant or planning to become pregnant or are breast-feeding
Are taking any heart medications or drugs to treat depression

Read the step by step Patient's Instruction for use before using this medicine.

Remember to vigorously shake your COMBIVENT Inhalation Aerosol for 10 seconds before each use or inhalation. Do not get the spray into your eyes.

For full prescribing information, please visit www.Combivent.com.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and approximately 41,300 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of US $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.