Global pharma major Lupin Limited on Wednesday announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Formoterol Fumarate Inhalation Solution, 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.
According to a press statement, Formoterol Fumarate Inhalation Solution (RLD Perforomist) had estimated annual sales of USD 282 million in the U.S. (IQVIA MAT June 2022).
This solution is usually indicated for to treat Chronic Obstructive Pulmonary Disease (COPD) in adults. COPD is a condition that includes several lung diseases that get worse over time, such as emphysema and chronic bronchitis.