Lupin gets nod from USFDA for Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 ml; Stock gains 1.5%

9 Feb 2022 , 02:35 PM

Global pharma major Lupin Limited on Tuesday announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), 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, the company said.

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

At around 2.40 pm, Lupin Ltd was trading at Rs800.05 per share up by Rs12.25 or 1.55% from its previous closing of Rs787.80 per share on the BSE.