FDA approves Merck' & Co's Dulera for asthma in patients; firm initiates Ph II trial of Chagas drug candidate
US drug giant Merck & Co had two pieces of good news yesterday; it received US regulatory clearance for a new fixed-dose combination asthma drug and initiated mid-stage research for a potential Chagas disease treatment.
In the first, the US Food and Drug Administration said it had 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. The approval 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.
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