Lupin gets USFDA Tentative nod for Arformoterol Tartrate Inhalation Solution
Mumbai, Baltimore: Lupin Limited has received tentative approval for its Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 mL, Unit-dose Vials, from the United States Food and Drug Administration (U.S. FDA) to market a generic version 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 15 mcg (base)/2 mL, Unit-dose Vials (RLD: Brovana®) had annual sales of approximately USD 489 million in the U.S. (IQVIA MAT Feb 2020).
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.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas.
The Company invests 9.6 % of its revenues on research and development.