Category: Approval/Launch Region: Asia · India Company: Lupin Ltd

Lupin gets USFDA nod for Formoterol Fumarate inhalation solution

Lupin gets USFDA nod for Formoterol Fumarate inhalation solution
Formoterol Fumarate inhalation solution is a generic equivalent of Perforomist inhalation solution of Mylan specialty Lupin Limited announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for 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 had estimated annual sales of USD 282 million in the U.S

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