Alembic Pharmaceuticals announces US FDA final approval for formoterol fumarate inhalation solution

Alembic Pharmaceuticals today announced that it has received final approval from the US Food and 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, LP 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 company said via a statement.

It also said that this ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies.

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