Glenmark Pharmaceuticals’ subsidiary -- Glenmark Specialty SA (Glenmark) has received final approval by the United States Food & Drug Administration (USFDA) 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 commercialization.
Glenmark’s Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA starting in March 2026. The approval further strengthens Glenmark’s respiratory portfolio in the U.S. and underscores its commitment to expanding access to quality inhalation therapies.
Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.
