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FDA Approves Merck's Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol for the Treatment of Asthma in Patients 12 Years of Age and Older
Posted 24 Jun 2010 by Drugs.com
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Jun 24, 2010 - Merck today announced that the U.S. Food and Drug Administration (FDA) has approved Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 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 patients 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," said Michael S. Blaiss, M.D., clinical professor of pediatrics and medicine at the ... Read more