Alembic Pharmaceuticals receives USFDA final approval for Arformoterol Tartrate Inhalation Solution

11 May 2022 , 11:39 AM

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) 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 longacting 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. 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. Powered by Capital Market – Live News