Lupin bags USFDA nod for generic equivalent of Brovana Inhalation Solution

Mumbai: Global pharma major Lupin Limited has recently announced that the company has 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.

The product is a generic equivalent of Brovana Inhalation Solution, 15 mcg /2 ml of Sunovion Pharmaceuticals Inc.

Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 ml, Unit-dose Vials are indicated for the long-term maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Arformoterol Tartrate Inhalation Solution is for use by nebulization only.

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Arformoterol Tartrate Inhalation Solution (RLD: Brovanas Inhalation Solution) had estimated annual sales of USD 251 million in the U.S. (IQVIA MAT December 2021).

The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APls 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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