Glenmark Specialty SA has received final US Food and Drug Administration (FDA) approval for a generic version of fluticasone propionate inhalation aerosol, 44 mcg per actuation, a treatment used in the management of asthma.
The product has been determined by the FDA to be bioequivalent and therapeutically equivalent to GlaxoSmithKline's reference listed drug, Flovent HFA Inhalation Aerosol 44 mcg.
Glenmark has been designated as the first approved applicant under the Competitive Generic Therapy (CGT) framework, making it eligible for 180 days of market exclusivity upon commercialisation.
The product will be distributed in the US by Glenmark Pharmaceuticals Inc., USA from March 2026. According to IQVIA sales data for the 12 months to January 2026, the Flovent HFA 44 mcg market generated annual sales of approximately $520 million.
Marc Kikuchi, president and business head for North America at Glenmark, said the approval marked "an important milestone" in strengthening the company's respiratory portfolio, adding that the CGT designation reflected the technical expertise of its teams in bringing complex inhalation therapies to market.
Glenmark said the approval underscored its commitment to expanding access to affordable respiratory treatments for patients and healthcare providers in the US.
Glenmark wins FDA approval for fluticasone propionate aerosol inhaler
