FDA tentatively approves Lupin’s generic arformoterol tartrate inhalation solution

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.

In 2012, Sunovion settled a patent infringement suit with Mylan, acknowledging that Brovana infringed on two Mylan patents for Perforomist formoterol fumarate inhalation solution.

Read the Lupin press release.