Lupin Receives Approval from U.S. FDA for Arformoterol Tartrate Inhalation Solution15 mcg (base)/2 ml

Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 ml, Unit-dose Vialsto market a generic equivalent of Brovana®Inhalation Solution, 15 mcg/2 ml of Sunovion Pharmaceuticals Inc. (Sunovion).

Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 ml, Unit-dose Vials 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 is for use by nebulization only.

Arformoterol Tartrate Inhalation Solution (RLD: Brovana® Inhalation Solution) had estimated annual sales of USD 251million in the U.S. (IQVIA MAT December 2021).