The FDA has now fully approved Lupin’s ANDA for its generic version of Sunovion’s Brovana arformoterol tartrate inhalation solution for the treatment of COPD. Brovana was approved by the FDA in 2006.
The agency tentatively approved Lupin’s ANDA for the arformoterol tartrate inhalation solution in April 2020, and in June 2021, Lupin announced the launch of an authorized generic of Brovana. That same month, the FDA granted final approval to generics of Brovana from Cipla and Glenmark. According to the FDA web site, Teva and Axar Pharma also received approvals for their versions of the inhalation solution in 2021.
Read the Lupin press release.
