Lupin has announced the US launch of an authorized generic version of Sunovion’s Brovana arformoterol tartrate inhalation solution for the treatment of COPD. The FDA tentatively approved the company’s ANDA for the inhalation solution in April 2020.
The FDA approved Brovana for the treatment of COPD in 2006, requiring a post-marketing safety study. In 2013, Sunovion announced results from a safety study that showed no increased risk.
Lupin’s arformoterol tartrate inhalation solution is the first generic version of Brovana available in the US. According to the FDA web site, three other companies have received tentative approval for generic arformoterol tartrate inhalation solutions: Teva in 2016, Cipla in 2017, and Axar Pharma earlier this year.
Read the Lupin press release.
