Pharmacy News Article

Jun 25, 2010 (Datamonitor via COMTEX) Merck today has reported that the FDA has approved Dulera inhalation aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older.

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.

Dulera 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. The recommended starting dose is based on prior asthma therapy.

The maximum daily recommended dose is two inhalations of Dulera 200mcg/5mcg twice daily every day in the morning and evening. Dulera is expected to be available in retail pharmacies across US by the end of July 2010.

Dulera is not indicated for the relief of acute bronchospasm. Dulera combines an inhaled corticosteroid with a long-acting beta2-agonist, Merck said.

James Fish, executive director of global scientific affairs at Merck Research Laboratories, said: "As a leader in researching and developing new treatments for respiratory diseases, including asthma, Merck is committed to bringing forth medicines that help meet the needs of healthcare professionals and their patients. Dulera represents an important part of this ongoing commitment."

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