Overview
- The FDA approved the first generic fluticasone propionate metered‑dose inhaler at 44 mcg per actuation for maintenance therapy in patients aged 4 years and older.
- Glenmark Specialty SA is the first approved applicant with a Competitive Generic Therapy designation and is eligible for 180 days of market exclusivity once commercialized.
- Glenmark says U.S. distribution will begin in March 2026, with availability expected as soon as this month.
- Regulators state the product is bioequivalent to the reference inhaler and will carry the same safety labeling, with the aim of broadening availability and reducing costs.
- The decision follows GSK’s 2024 removal of branded Flovent inhalers that prompted treatment disruptions and a Senate investigation into access and coverage issues.