Lupin gets USFDA tentative approval for inhalation solutions

Lupin Limited has received a tentative approval for its Arformoterol Tartrate inhalation solution 15 mcg (base)/2 ml, unit-dose vials, from United States Food & Drug Administration (USFDA) to market generic version 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.

Bronchoconstriction is a condition in which the smooth muscles of the bronchus contracts. The bronchus is the pathway that moves air to-and-fro the lungs. It usually occurs in asthma, emphysema and other lung diseases.

As per IQVIA MAT Feb 2020s data, Arformoterol Tartrate inhalation solution 15 mcg (base)/2 ml, unit-dose vials (RLD: Brovana) had an annual sales of approximately USD 489 million in US.

Lupin Ltd is a transnational pharmaceutical company which develops and commercialises a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in US, India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe as well as Middle-East regions.

On Wednesday, the stock of Lupin opened at Rs 868.95. During the day, it surged 2.2 per cent, making an intraday high of Rs 872.75 from its previous close of Rs 854.35 on BSE.