The FDA has announced the approval of Boehringer Ingelheim’s Striverdi Respimat olodaterol SMI for the treatment of COPD. The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended approval of Striverdi Respimat in January 2013. The soft mist inhaler was approved in the EU in October 2013.
Curtis Rosebraugh, Director of the Office of Drug Evaluation II in the FDA Center for Drug Evaluation and Research said, “The availability of this new long-term maintenance medication provides an additional treatment options for the millions of Americans who suffer with COPD.”
Striverdi Respimat will carry a boxed warning about the risk of asthma-related death with use of LABAs. The agency notes that the product can cause bronchospasm and pointed out that the inhaler is not approved for the treatment of asthma, should not be used as a rescue inhaler, and “should not be used in patients with acutely deteriorating COPD.”
Read the FDA press release.
