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news.Merck has received FDA approval for Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older.
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The approval of Dulera is based, in part, on Phase III studies that evaluated the safety and efficacy in patients 12 years of age and older with persistent asthma.
Dulera combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate) and is indicated for the treatment of asthma in patients 12 years of age and older. Dulera is not indicated for the relief of acute bronchospasm.
Dulera is a pressurised metered-dose inhaler with a built-in numeric counter that shows the number of remaining doses.
Merck said that the inhaler will be available for patients 12 years of age and older in two strengths: Dulera 100mcg/5mcg and Dulera 200mcg/5mcg.
Each inhalation contains 5mcg of formoterol fumarate and either 100mcg or 200mcg of mometasone furoate. Dulera is expected to be available in retail pharmacies nationwide by the end of July 2010.