FDA approves Merck's Dulera

FDA approved an NDA from Merck & Co. Inc. (NYSE:MRK) for Dulera mometasone/formoterol inhalation aerosol to treat asthma in patients 12 years and older. The company expects to launch Dulera by the end of July. Dulera's label includes a boxed warning that long-acting adrenergic receptor beta agonists (LABAs), such as formoterol, may increase the risk of asthma-related death. It also warns that Dulera should only be prescribed for asthma patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity warrants initiation of treatment with both an inhaled corticosteroid and a LABA. The warnings are in line with FDA requirements announced in February (See BioCentury Extra, Thursday, Feb. 18, 2010). ...