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FDA Approves Dulera® Inhalation Aerosol for the Treatment of Asthma

The U.S. Food and Drug Administration has approved Merck’s Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for people 12 years of age and older. Dulera is not indicated for the relief of acute bronchospasm.

Dulera combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate). The approval of Dulera is based, in part, on Phase III studies that evaluated the safety and efficacy of Dulera in people 12 years of age and older with persistent asthma.

“Despite the advances made in the treatment of asthma in recent years, many patients may still not be well-controlled on their current therapies,” says Michael S. Blaiss, MD, clinical professor of Pediatrics and Medicine at the University of Tennessee Health Science Center in Memphis. “Asthma control is an important treatment goal, and Dulera provides a new option for physicians to help manage this chronic condition in appropriate patients.”


This article was originally published in Coping® with Allergies & Asthma magazine, Winter 2010-2011.