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Schering-Plough Announces Changes to its Global Collaboration with Novartis to Develop Combination Therapies for Asthma and COPD
Date:5/18/2009

FORADIL AEROLIZER is not indicated for patients whose asthma can be managed by occasional use of fast-acting rescue inhalers.

FORADIL AEROLIZER is also for the acute prevention of exercise-induced bronchospasm (EIB) in those 5 years of age and older when administered on an occasional, as-needed basis at least 15 minutes before exercise.

Important Safety Information

FORADIL belongs to a class of medications known as long-acting beta2-adrenergic agonists or LABAs. In patients with asthma, LABAs may increase the chance of asthma related death. Therefore, FORADIL should only be used as additional therapy for patients not adequately controlled on other asthma controller medications.

In COPD clinical trials, the most common adverse events reported with FORADIL AEROLIZER were upper respiratory infection, back pain, and sore throat.

In asthma clinical trials, the most common adverse events reported with FORADIL AEROLIZER were viral infection, bronchitis, and chest infection.

FORADIL capsules should only be inhaled orally using the AEROLIZER inhaler. The capsules should not be swallowed.

FORADIL AEROLIZER should not be used to treat acute symptoms. Acute symptoms should be treated with fast-acting rescue inhalers. Do not use more than one capsule twice daily. FORADIL AEROLIZER should be used with caution in patients with cardiovascular disorders. FORADIL AEROLIZER is not a substitute for inhaled or oral corticosteroids and, in the treatment of asthma, they should not be stopped or reduced at the time FORADIL AEROLIZER is initiated.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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