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FDA Approves Merck Asthma Drug Dulera

Merck received approval from the FDA for Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combo asthma treatment for patients 12 years of age and older.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Merck received approval from the FDA for Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combo asthma treatment for patients 12 years of age and older. Dulera combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate).

The approval is based on Phase III studies that evaluated the safety and efficacy of the drug in patients 12 years and older with persistent asthma. Results showed patients receiving Dulera (100 mcg/5 mcg or 200 mcg/5 mcg) experienced significant improvement in lung function at week 12, a primary efficacy endpoint in the trials, compared to mometasone furoate and placebo.

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