Alembic Pharmaceuticals Generic Formoterol Fumarate Inhalation Solution Approved

Alembic Pharmaceuticals has received FDA approval of its abbreviated new drug application (ANDA) for formoterol fumarate inhalation solution, 20 mcg/2 ml per unit-dose vial, a generic of Mylan Specialty’s Perforomist. 

The long-acting beta2-agonist is indicated for twice-daily administration for long-term treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

The ANDA, which was developed in partnership with Orbicular Pharmaceutical Technologies, is Alembic’s first inhalational ANDA approval.