Lupin receives tentative approval from US FDA for Revefenacin Inhalation Solution

Global pharma major, Lupin announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Revefenacin Inhalation Solution, 175 mcg/3 mL Unit-Dose Vials.

Lupin’s Revefenacin Inhalation Solution, 175 mcg/3 mL is bioequivalent to Mylan’s Yupelri Inhalation Solution and indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). 

Revefenacin Inhalation Solution (RLD Yupelri) had estimated annual sales of USD 260.7 million in the US. (IQVIA MAT March 2026).