Lupin gets USFDA nod for generic equivalent of Mylan Specialty Perforomist Inhalation Solution

Mumbai: Global pharma major, Lupin Limited, today announced that the company has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Formoterol Fumarate Inhalation Solution, 20 mcg/2 mL per Unit-Dose Vial.

The product is a generic equivalent of Perforomist Inhalation Solution, 20 mcg/2 mL, of Mylan Specialty, L.P.

PERFOROMIST Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for:

 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. 

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

Medical Dialogues team had earlier reported that Lupin had received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 ml, Unit-dose Vials.

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Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions. The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women's health areas.

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