Glenmark receives USFDA approval for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg

Glenmark Specialty SA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. 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 equivalent1 to the reference listed drug (RLD), FloVent2 HFA Inhalation Aerosol, 44 mcg of GlaxoSmithKline Intellectual Property Ltd. England (NDA - 021433).

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.

According to IQVIA sales data for the 12-month period ending January 2026, the FloVent HFA Inhalation Aerosol, 44 mcg market3 achieved annual sales of approximately $520.1 million.

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