Glenmark has received final approval by the United States Food and Drug Administration (FDA) for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation.

Glenmark's Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation has been determined by the FDA to be bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), FloVent HFA Inhalation Aerosol, 44 mcg of GlaxoSmithKline Intellectual Property.

Glenmark has been granted a Competitive Generic Therapy (CGT) 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. Therefore, with this approval, Glenmark is eligible for 180 days of CGT exclusivity upon commercialisation.

Glenmark's Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation will be distributed in the US by Glenmark Pharmaceuticals Inc., USA starting in March 2026. The approval further strengthens Glenmark's respiratory portfolio in the US and underscores its commitment to expanding access to quality inhalation therapies.

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

Commenting on the launch, Marc Kikuchi, President and Business Head, North America, said, "Receiving approval for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation marks an important milestone in strengthening our respiratory portfolio in the US. The CGT designation and first approved applicant status reflect the technical expertise and dedication of our teams in bringing complex inhalation therapies to market. We remain committed to improving access to quality and affordable respiratory treatments for patients and healthcare providers."

Glenmark's Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation is only approved for the indication(s) listed in Glenmark's approved label.