According to Lupin, the FDA has approved the company’s ANDA for a generic version of Mylan’s Perforomist formoterol fumarate inhalation solution. Teva launched a generic equivalent in the US in June 2021 after expiration of the final patent covering Perforomist, and the agency approved Alembic Pharmaceuticals’ ANDA for its Perforomist equivalent in November 2021.
Earlier this year, the agency approved Lupin’s generic version of Sunovion’s Brovana arformoterol tartrate inhalation solution for the treatment of COPD. Other recent generic inhaled product approvals for Lupin include its equivalent to Teva’s ProAir HFA albuterol MDI in August 2020 and generics of AstraZeneca’s Pulmicort Respules budesonide inhalation suspension and Tobi tobramycin inhalation solution.
Read the Lupin press release.
