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www.fdanews.com/articles/167481-fda-approves-boehringer-ingelheims-copd-drug-spiriva-respimat

FDA Approves Boehringer Ingelheim’s COPD Drug Spiriva Respimat

September 30, 2014

Boehringer Ingelheim won FDA approval last week for its chronic obstructive pulmonary disease (COPD) drug Spiriva Respimat and plans to launch the drug by the new year.

The product, a combination of BI’s Spiriva (tiotropium bromide) inhaled mist and Respimat inhaler, is indicated for long-term reduction of exacerbations and maintenance of bronchospasm in COPD patients.

Spiriva Respimat is the second Spiriva product to be approved in the U.S., BI says. Two other Respimat-based treatments also are available in the U.S. They are BI’s Combivent Respimat, approved in 2011, and BI’s Striverdi Respimat. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.