FDA
FDA greenlights first true generic of Flovent HFA inhaler for asthma
Approval date: March 3, 2026
FDA approved the first true generic version of Flovent HFA (fluticasone propionate inhaled) for asthma maintenance in patients 4 years and older. This metered dose inhaler delivers 44 mcg of fluticasone propionate per actuation and has the same contraindications, warnings, and precautions as the original Flovent HFA product.
The new product from Glenmark Specialty arrives amid ongoing access and insurance challenges following GlaxoSmithKline's discontinuation of Flovent HFA in 2023. Although an authorized generic is already available, this approval is considered the first true generic because it comes from an independent manufacturer. It potentially offers a more affordable option for many patients. Glenmark’s inhaler also received a Competitive Generic Therapy designation, granting 180 days of market exclusivity once launched—an incentive aimed at encouraging development of complex, hard‑to‑manufacture generics like inhalation therapies.
Sources:
FDA. (2026, March 3). FDA approves first generic of Flovent HFA for treatment of asthma. [Press release]. https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-first-generic-flovent-hfa-treatment-asthma
Glenmark Pharmaceuticals Inc. (2026, March 4). Glenmark Specialty SA Receives U.S. FDA Approval for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation, with 180-Day Competitive Generic Therapy Exclusivity. [Press release]. https://glenmarkpharma-us.com/press/glenmark-specialty-sa-receives-u-s-fda-approval-for-fluticasone-propionate-inhalation-aerosol-usp-44-mcg-per-actuation-with-180-day-competitive-generic-therapy-exclusivity/