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Lupin receives US FDA approval for inhalation drug

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Lupin receives US FDA approval for inhalation drug

Global pharma major Lupin Limited (Lupin) has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Formoterol Fumarate Inhalation Solution.

Formoterol oral inhalation is used to control wheezing, shortness of breath, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). Formoterol is in a class of medications called long-acting beta agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.

Formoterol Fumarate Inhalation Solution available in 20 mcg/2 mL per Unit-Dose Vial, to market a generic equivalent of Perforomist Inhalation Solution, 20 mcg/2 mL, of Mylan Specialty, L.P.

Formoterol Fumarate Inhalation Solution (RLD Perforomist) had estimated annual sales of USD 282 million in the U.S. (IQVIA MAT June 2022).