Glenmark Therapeutics Inc., USA launches Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC)
2026-03-19 · Glenmark Pharmaceuticals Ltd. India · original glenmarkpharma.com ↗
Glenmark Therapeutics Inc., USA launches Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC) Elmwood Park , New Jersey, March 19, 202 6 – Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC). Glenmark’s Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC) has been determined by the FDA to be bioequivalent 1 to the reference listed drug, Flonase®2 Allergy Relief Nasal Spray, 50 mcg per spray, of Haleon US Holding LLC [NDA – 205434]; and will be distributed in the U.S. by Glenmark Therapeutics Inc., USA. According to Nielsen® syndicated data for the latest 52-week period ending March 3, 2026, the Flonase® Allergy Relief Nasal Spray, 50 mcg per spray market3 achieved annual sales of approximately $384.7 million*. Commenting on the launch, Marc Kikuchi, President & Business Head, North America said, “We are excited to announce the recent approval of Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC). As the first approved nasal spray distributed by Glenmark Therapeutics Inc., USA in the OTC space, we look forward to bringing this quality over-the- counter solution to our customers when we launch in April 2026.” 1Glenmark’s Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC) is only marketed for the indications listed in Glenmark’s approved drug facts label. 2This product is not manufactured or distributed by Haleon and/or GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) IP LIMITED, distributor of FLONASE® Allergy Relief and owner of the registered trademark FLONASE®, respectively. [Neither Haleon nor GLAXOSMITHKLINE C ONSUMER HEALTHCARE (UK) IP LIMITED make or license Glenmark’s product.] 3Market includes brand and all available therapeutic equivalents. Note: Nielsen syndicated data obtained by Glenmark is only available for all approved RLD indications. Glenmark’s product is only approved for the indications listed in Glenmark’s approved label and is not marketed for all RLD indications. *Nielsen® NIQ Discover; Syndicated Data for Period Ending March 3, 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: In the U.S.: Akhila Natarajan [email protected] +91 98216 89525 Danielle Hagen, Nahigian Strategies [email protected] 202-365-6112 In India: Akhila Natarajan [email protected] +91 98216 89525 Adfactors PR [email protected] +91 88502 91322
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