Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (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 US$ 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 US FDA, including this second inhalational ANDA approval.
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
