Alembic Pharmaceuticals receives USFDA final approval for Arformoterol Tartrate Inhalation Solution

13 May 2022 , 01:31 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 base2 ml Unit-dose Vial The approved ANDA is therapeutically equivalent to the reference listed drug product RlD Brovana Inhalation Solution 15 mcg2 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 base2 ml Unit-dose Vial has an estimated market size of US$ 251 million for twelve months ending December 2021 according to IQVIA