According to Lupin, the FDA has tentatively approved the company’s arformoterol tartrate inhalation solution, a generic version of Sunovion’s Brovana, for the treatment of COPD. Sunovion’s final patent covering Brovana expires in November 2021.
Brovana was originally approved by the FDA for the treatment of COPD in 2006. A post-marketing study commitment required safety studies of the inhalation solution, and in 2013, Sunovion announced that a safety study demonstrated no increased risk for Brovana.
Read the Lupin press release.
