The solution is the bioequivalent of Reference Listed Drug Brovana Inhalation Solution of Sunovion Pharmaceuticals Inc.

Baltimore: Global pharma major Lupin Limited received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 ml unitdose vials. The solution is the bioequivalent of Reference Listed Drug Brovana Inhalation Solution of Sunovion Pharmaceuticals Inc. Unit-dose vials of Arformoterol Tartrate Inhalation Solution are indicated for the long-term maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Arformoterol Tartrate Inhalation Solution can be administered through solely nebulization to the patient. According to IQVIA MAT December 2021, Arformoterol Tartrate Inhalation Solution had an estimated annual sales of USD 251 million in the United States pharmaceutical market.