Glenmark Specialty SA, a subsidiary of Glenmark Pharmaceuticals Ltd. (532296) Wednesday announced that the U.S. FDA has granted final approval for its Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation.
The product has been deemed bioequivalent and therapeutically equivalent to GlaxoSmithKline's FloVent HFA Inhalation Aerosol, a widely used treatment for asthma.
With this approval Glenmark has also secured Competitive Generic Therapy designation, making it the first approved applicant and eligible for 180 days of market exclusivity in the United States. The inhaler will be distributed in the U.S., beginning March 2026, strengthening Glenmark's respiratory portfolio and expanding access to affordable inhalation therapies.
According to IQVIA sales data, the FloVent HFA market generated approximately $520.1 million in annual sales for the 12-month ending January 2026.
Marc Kikuchi, President & Business Head, North America, commented: "We remain committed to improving access to quality and affordable respiratory treatments for patients and healthcare providers."
Glenmark has traded between INR 1,327.75 and INR 2,286.15 over the past year. The stock closed Wednesday's trading at INR 2040.10, down 3.93%.
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