Alembic Pharma bags US FDA approval for Arformoterol Tartrate Inhalation Solution

The solution is indicated for maintenance treatment of bronchoconstriction in patients with COPD

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 mL Unit-dose Vial. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Brovana Inhalation Solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc. Arformoterol Tartarate 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 Private Limited.

Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 mL Unit-dose Vial, has an estimated market size of $251 million for twelve months ending December 2021 according to IQVIA.

Alembic has a cumulative total of 167 ANDA approvals (143 final approvals and 24 tentative approvals) from the US FDA, including this second inhalational ANDA approval.