drugset / Press release

Glenmark Pharmaceuticals receives U.S. FDA approval for Fluticasone Propionate Nasal Spray, 0.05 mg (50 mcg)/spray

2026-08-20 · Glenmark Pharmaceuticals Ltd. India · original glenmarkpharma.com ↗

Glenmark Pharmaceuticals receives U.S. FDA approval for Fluticasone Propionate Nasal Spray, 0.05 mg (50 mcg)/spray Elmwood Park, New Jersey, August 20, 2026 – Glenmark Pharmaceuticals Limited (Glenmark) today announced the receipt of U.S. FDA approval1 for Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray. Glenmark’s Fluticasone Propionate Nasal Spray USP is bioequivalent and therapeutically equivalent to the reference listed drug, Flonase ®2 Nasal Spray, 0.05 mg/spray of Haleon US Holdings LLC [ NDA 020121 ] and will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA. According to IQVIA® sales data for the 12 -month period ending June 2026, the Flonase® Nasal Spray market3 achieved annual sales of approximately $295.2 million*. Commenting on the approval, Marc Kikuchi, President & Business Head, North America said, “The approval of Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray marks another step in expanding our respiratory portfolio in the U.S. and builds on the strong foundation we have established in this therapeutic area. We remain committed to broadening access to quality, affordable treatment options that address the evolving needs of patients and healthcare providers.” 1Glenmark’s Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray is only approved for the indication(s) listed in Glenmark’s approved label. 2All brand names and trademarks are the property of their respective owners. 3Market includes brand and all available therapeutic equivalents. Note: IQVIA ® data obtained by Glenmark is only available for all approved RLD indications. Glenmark’s product is only approved for and will only be marketed for the indications listed in Glenmark’s approved label, which may be different than the approved RLD indications. *IQVIA® National Sales Perspectives: Retail & Non-Retail, June 2026 About Glenmark Pharmaceuticals Limited Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is a global, research ‐led pharmaceutical company with a unique focus on innovation and accessibility. We pioneer transformative breakthrough therapies that aim to redefine treatment while expanding access to high quality and affordable medicines for patients around the world. With 11 world -class manufacturing facilities across four continents, supported by six cutting -edge R&D centres, and a commercial footprint in 80+ countries, we deliver a diversified portfolio across branded, innovative, generics, and consumer health products, with a focus on respiratory, dermatology, and oncology. Scrip 100 positions Glenmark among the Top 100 biopharmaceutical companies globally by pharmaceutical sales for 2024. For more information, visit www.glenmarkpharma.com. For more information, please contact: India United States Akhila Natarajan | [email protected] Adfactors PR | [email protected] Akhila Natarajan | [email protected] Danielle Hagen | [email protected]

The release as fetched from its publisher. glenmarkpharma.com ↗