Lupin receives US FDA tentative approval for Revefenacin Inhalation Solution
Jagruti Jain
Lupin Limited on Monday announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Revefenacin Inhalation Solution, 175 mcg/3 mL Unit-Dose Vials.
The company said the product is bioequivalent to Mylan’s Yupelri Inhalation Solution and is indicated for the maintenance treatment of patients suffering from Chronic Obstructive Pulmonary Disease (COPD).
According to the company, the reference listed drug (RLD) Yupelri had estimated annual sales of approximately $260.7 million in the US market for the period ending March 2026, citing IQVIA MAT data.
Lupin stated that the approval strengthens its respiratory portfolio in the US market, where the company already has a significant presence across branded and generic pharmaceutical products.
Headquartered in Mumbai, Lupin operates across more than 100 markets globally and has a portfolio spanning respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal and central nervous system therapies.
Disclaimer: This article is based on the company’s exchange filing and is meant for informational purposes only.