Lupin announced that the FDA has approved the company’s ANDA for its generic of Boehringer Ingelheim’s Spiriva HandiHaler tiotropium bromide inhalation powder. Health Canada approved the company’s tiotropium DPI earlier this year. In the UK, the DPI was approved in August 2022. According to Lupin, the company manufactures the product at its site in Pithampur, India.
Lupin CEO Vinitia Gupta commented, “We are delighted to receive the final approval for generic Spiriva HandiHaler from the US FDA. 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 US, and is also the first DPI approval from India for the US. This is an important milestone in our journey of building our respiratory franchise globally.”
Read the Lupin press release.
