Glenmark Obtains US FDA Approval for Fluticasone Propionate Inhalation Aerosol

Glenmark Specialty SA has received final approval from the US Food and Drug Administration for its Fluticasone Propionate Inhalation Aerosol USP, 44 mcg, a generic equivalent to GlaxoSmithKline's FloVent HFA Inhalation Aerosol. The drug has been granted Competitive Generic Therapy designation, making Glenmark eligible for 180 days of market exclusivity upon commercialization, expected in March 2026. This approval enhances Glenmark's respiratory portfolio in the US, with the FloVent market generating about $520 million in annual sales.