Glenmark Secures US FDA Approval for Fluticasone Propionate Inhalation Aerosol

Glenmark Pharmaceuticals' subsidiary, Glenmark Specialty SA, has received final US FDA approval for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg, a generic equivalent to GlaxoSmithKline's Flovent HFA. The product has been granted Competitive Generic Therapy designation, making Glenmark eligible for 180 days of market exclusivity upon launch, expected in March 2026. This approval enhances Glenmark's respiratory portfolio in the US, a market with annual sales around $520 million for the reference drug.