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Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma
Date:7/22/2009

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About FORADIL((R))

FORADIL((R)) AEROLIZER((R)) is for the maintenance treatment of asthma in those 5 years and older when taken on a long-term, twice-daily basis. FORADIL AEROLIZER should only be used as additional therapy for patients not adequately controlled on other asthma controller medications.

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.

FORADIL AEROLIZER is for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.

Important Safety Information for FORADIL AEROLIZER

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

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

FORADIL capsules should only be inhaled orally us
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SOURCE Schering-Plough Corporation
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