Alembic Pharmaceuticals gets FDA approval for Formoterol Fumarate Inhalation Solution

Alembic Pharmaceuticals said that it has secured final approval from the US Food and Drug Administration (FDA) for Formoterol Fumarate Inhalation Solution, 20 mcg/2 ml per Unit-Dose Vial.

The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to Perforomist Inhalation Solution, 20 mcg/2 ml per Unit-Dose Vial, the reference listed drug product (RlD) owned by Mylan Specialty.

According to Alembic Pharmaceuticals, Formoterol Fumarate Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) approved to be used for lonq-term, twice daily for the maintenance treatment of bronchoconstriction in patients suffering from chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis.

The ANDA has been jointly developed with Orbicular Pharmaceutical Technologies.

According to IQVIA, Formoterol Fumarate Inhalation Solution, 20 mcg/2 ml per Unit-Dose Vial, has an estimated market size of $310 million for 12 months ending September 2021.