Alembic Pharmaceuticals has received final approval from the U.S. Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Formoterol Fumarate Inhalation Solution, 20 mcg/2 ml per Unit-Dose Vial.

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 long-term, 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.

The 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 Sep. 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.