USFDA18 May 2026, 09:21 pm
Lupin Gets Tentative U.S. FDA Nod for Revefenacin Inhalation
AI Summary
Lupin Ltd. has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for Revefenacin Inhalation Solution, 175 mcg/3 mL Unit-Dose Vials. This product is bioequivalent to Mylan’s Yupelri® Inhalation Solution and is indicated for maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD). The estimated annual sales for Revefenacin Inhalation Solution (RLD Yupelri®) were USD 260.7 million in the U.S. (IQVIA MAT March 2026).
Key Highlights
- Lupin receives tentative U.S. FDA approval for Revefenacin Inhalation Solution.
- The drug is bioequivalent to Mylan’s Yupelri® for COPD treatment.
- Yupelri® had U.S. sales of USD 260.7 million (IQVIA MAT March 2026).
- Lupin aims to improve patient outcomes via subsidiaries.