The approved ANDA is therapeutically equivalent to the reference listed drug product (RlD), Perforomist Inhalation Solution, 20 mcg/2 ml per Unit-Dose Vial, of Mylan Specialty, L.P. Formoterol Fumarate Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for lonqterm, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies.

Formoterol Fumarate Inhalation Solution, 20 mcg/2 ml per Unit-Dose Vial, has an estimated market size of US$ 310 million for twelve months ending September 2021 according to IQVIA.

Alembic has received year to date (YTD) 14 approvals (11 final approvals and 3 tentative approvals) and a cumulative total of 153 ANDA approvals (134 final approvals and 19 tentative approvals) from USFDA, including this first inhalational ANDA approval.