Lupin receives USFDA approval for Formoterol Fumarate Inhalation Solution

Lupin today 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.

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

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