The FDA has accepted Boehringer Ingelheim’s New Drug Application for its tiotropium/olodaterol Respimat soft mist inhaler for the treatment of COPD, the company has announced.
BI’s Striverdi Respimat olodaterol SMI was approved by the FDA at the end of July 2014, and the agency’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) recently voted in favor of approval for tiotropium Respimat.
BI Senior VP, Medicine & Regulatory Affairs Sabine Luik commented, “The FDA’s acceptance of our application for the fixed-dose combination of tiotropium and olodaterol is an important milestone for our company, and it reinforces Boehringer Ingelheim’s steadfast commitment to COPD.”
The company submitted an MAA for the tiotropium/olodaterol Respimat to the EMA in July 2014.
Read the BI press release.
