Lupin receives USFDA tentative approval for Arformoterol Tartrate Inhalation Solution

Lupin announced 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 (U.S. FDA) to market a generic version 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 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).

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