The FDA has approved Aucta Pharmaceuticals’ ANDA for its formoterol fumarate inhalation solution, a generic version of Mylan’s Perforomist. Aucta’s is the 4th Perforomist equivalent approved since the expiration of Mylan’s final patent covering the inhalation solution.
Teva launched its generic equivalent in the US in June 2021, and the FDA approved Alembic Pharmaceuticals’ version of Perforomist in November 2021. Lupin’s generic formoterol inhalation solution was approved in August 2022, and the company has just announced its launch.
Aucta Pharmaceuticals Chief Commercial Officer Brian Zorn commented, “We are pleased to have our third Aucta Pharmaceuticals-developed product approved for the US market. This marks the launch of our new commercial infrastructure to commercialize this and future products in the US.”
Read the Aucta Pharmaceuticals press release.
