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Lupin bags US FDA approval for Arformoterol Tartrate Inhalation Solution

The drug is indicated for the long-term maintenance treatment of bronchoconstriction in patients with COPD

Lupin 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 Vials to market a generic equivalent of Brovana Inhalation Solution, 15 mcg /2 ml of Sunovion Pharmaceuticals (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 had estimated annual sales of $251 million in the US.

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