Glenmark Specialty SA Gets US FDA Approval for Fluticasone Propionate

Glenmark Specialty SA has received final approval from the United States Food and Drug Administration for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation.

Glenmark stated that its Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation, has been determined by the US FDA to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), FloVent HFA Inhalation Aerosol, 44 mcg, of GlaxoSmithKline Intellectual Property Ltd, England (NDA 021433).

The company has been granted a Competitive Generic Therapy designation for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation, and is the “first approved applicant” as defined in section 505(j)(5)(B)(v)(III) of the FD&C Act. Consequently, with this approval, Glenmark is eligible for 180 days of Competitive Generic Therapy exclusivity upon commercialisation.

Glenmark Pharmaceuticals Inc, USA will commence distribution of the product in the US starting in March 2026. A company statement noted that the approval strengthens Glenmark’s respiratory portfolio in the US and aims to expand access to quality inhalation therapies.

 According to IQVIA sales data for the 12-month period ending January 2026 cited by the company, the FloVent HFA Inhalation Aerosol, 44 mcg market, achieved annual sales of approximately $520.1 million.