Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) 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.
This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
