Global pharma major Lupin Limited announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application, Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 ml, Unit-dose Vials to market a generic equivalent of Brovana ® Inhalation Solution, 15 mcg /2 ml of Sunovion Pharmaceuticals Inc. (Sunovion).
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.
Arformoterol Tartrate Inhalation Solution (RLD: Brovanas Inhalation Solution) had estimated annual sales of USD 251 million in the U.S. (IQVIA MAT December 2021).
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 the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
