Boehringer Ingelheim announced that the FDA has approved Combivent Respimat (ipratropium bromide and albuterol), a propellant-free metered dose inhalation spray that uses a slow-moving mist, for the treatment of chronic obstructive pulmonary disease (COPD). Combivent Respimat is indicated for use in patients on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator. This approval was based on data from a 12-week, randomized, double-blind, placebo and active-controlled clinical trial in which Combivent Respimat was shown to be clinically comparable to Combivent metered-dose inhaler (MDI), in terms of FEV1.
Combivent Respimat is expected to be available mid-2012. To allow adequate time to transition, the Combivent MDI will continue to be available until late 2013.
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