The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of arformoterol tartrate inhalation solution 15 mcg (base)/2 ml, unit-dose vials.
Homegrown pharma major Lupin Ltd on Tuesday said it has received approval from the US health regulator for its generic version of arformoterol tartrate inhalation solution, used in the treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD).
The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of arformoterol tartrate inhalation solution 15 mcg (base)/2 ml, unit-dose vials, the company said in a regulatory filing.
It is a generic equivalent of Brovana inhalation solution, 15 mcg/2 ml of Sunovion Pharmaceuticals Inc, it added.
The solution is indicated for the long-term maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, it added.
Arformoterol Tartrate Inhalation Solution is for use by nebulization only, the company said.
Citing IQVIA MAT December 2021 data, Lupin said arformoterol tartrate inhalation solution had an estimated annual sales of $251 million in the US.