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FDA approves Schering-Plough’s Asmanex

The FDA has approved the use of Schering-Plough's Asmanex Twisthaler for the once-daily management of asthma.

Asmanex Twisthaler 220mcg (mometasone furoate inhalation powder) is now approved for the first-line maintenance treatment of asthma as preventive therapy in patients 12 years of age and older.

Asmanex is now the only inhaled asthma controller therapy approved for once daily initiation and management of asthma in patients previously treated with bronchodilators alone or inhaled corticosteroids.

Clinical studies with Asmanex have shown substantial improvement in lung function, decreased use of rescue medication, decreased incidence of nighttime awakenings and significant improvements in daytime symptoms such as coughing and wheezing.

In one clinical trial, Asmanex showed substantial improvement in lung function and decreased albuterol (rescue medication) use compared with placebo. At endpoint, patients who received Asmanex had a significant improvement in nighttime awakenings and daytime symptoms – providing night and day relief.

The NAEPP (National Asthma Education and Prevention Program) asthma treatment guidelines recommend single-ingredient, low-dose inhaled corticosteroid as the foundation of therapy for mild persistent asthma management.