The FDA has approved Alembic Pharmaceuticals’ ANDA for its formoterol fumarate inhalation solution, a generic of Mylan’s Perforomist inhalation solution for the treatment of COPD, the company said. According to the announcement, this is the company’s first US approval for an inhaled product. Alembic said that it worked with Indian contract research organization Orbicular Pharmaceutical Technologies, which specializes in complex dosage forms, on development of the formulation.
Patents covering Perforomist expired in June 2021, and Teva launched a generic formoterol fumarate inhalation solution that same month.
Read the Alembic Pharmaceuticals press release.
