Glenmark Specialty SA, a subsidiary of Glenmark Pharmaceuticals Limited, has received final approval from the United States Food & Drug Administration (U.S. FDA) for its Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation. This approval confirms that Glenmark's product is bioequivalent and therapeutically equivalent to the reference listed drug, FloVent® HFA Inhalation Aerosol, 44 mcg, manufactured by GlaxoSmithKline Intellectual Property Ltd. England. Glenmark has been granted a Competitive Generic Therapy (CGT) designation and is recognized as the "first approved applicant," making it eligible for 180 days of CGT exclusivity upon commercialization. The product will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA, beginning in March 2026. This approval is expected to strengthen Glenmark's respiratory portfolio in the U.S. The market for FloVent® HFA Inhalation Aerosol, 44 mcg achieved annual sales of approximately $520.1 million (₹4,312.9 crore) for the 12 months ending January 2026, according to IQVIATM sales data. Marc Kikuchi, President & Business Head, North America, stated that the approval marks a significant milestone, highlighting the company's technical expertise in bringing complex inhalation therapies to market and its commitment to improving access to affordable respiratory treatments.
