The FDA has approved Lupin’s 18 µg capsules of tiotropium bromide inhalation powder, according to a manufacturer-issued press release.
The newly approved tiotropium bromide capsules manufactured by Lupin are a generic version of the Spiriva HandiHaler (Boehringer Ingelheim Pharmaceuticals Inc.), according to the release.
As Healio previously reported, daily tiotropium via the HandiHaler device improved lung function in adults with stable bronchiectasis but did not reduce frequency of exacerbations over 6 months.
“We are delighted to receive the final approval for generic Spiriva HandiHaler from the U.S. FDA,” Vinita Gupta, CEO of Lupin, said in the release. “This builds on our commitment to serving unmet needs for our patients across the world. This is the first generic approval for Spiriva HandiHaler in the U.S., and is also the first DPI approval from India for the U.S. This is an important milestone in our journey of building our respiratory franchise globally.”
According to the release, manufacturing will take place at Lupin’s India facility.