Lupin Receives Tentative Approval for Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 mL

Pharma major Lupin announced that it has received tentative approval for its Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 mL, Unit-dose Vials, from the United States Food and Drug Administration (US FDA) to market a generic version of Brovana Inhalation Solution, 15 mcg/2 mL of Sunovion Pharmaceuticals.

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 15 mcg (base)/2 mL, Unit-dose Vials (RLD: Brovana®) had an annual sales of approximately USD 489 million in the U.S. (IQVIA MAT Feb 2020).