Glenmark Specialty SA Receives U.S. FDA Approval for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation, with 180-Day Competitive Generic Therapy Exclusivity

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 equivalent to the reference listed drug (RLD), FloVent®2 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 IQVIATM 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*.

Commenting on the launch, Marc Kikuchi, President & 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 U.S. 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."

Shares of Glenmark Pharmaceuticals Limited was last trading in BSE at Rs. 2123.50 as compared to the previous close of Rs. 2137.70. The total number of shares traded during the day was 30966 in over 3594 trades.

The stock hit an intraday high of Rs. 2149.25 and intraday low of 1966.20. The net turnover during the day was Rs. 65516055.00.

Source : Equity Bulls

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GlenmarkPharmaceuticals INE935A01035 GlenmarkSpecialtySA USFDA Approval