Glenmark Pharmaceuticals Receives FDA Approval for Fluticasone Propionate Nasal Spray USP (OTC)

Glenmark Pharmaceuticals Receives FDA Approval for Fluticasone Propionate Nasal Spray USP (OTC)​

Elmwood Park, New Jersey, March 19, 2026 – Glenmark Pharmaceuticals Limited (Glenmark) announced it has received final approval from the United States Food & Drug Administration (U.S. FDA) for Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC). Glenmark’s product has been determined by the FDA to be bioequivalent to Flonase® 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 52-week period ending March 3, 2026, the Flonase® Allergy Relief Nasal Spray market achieved annual sales of approximately $384.7 million*.

"We are excited to announce the recent approval of Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC)," said Marc Kikuchi, President & Business Head, North America. "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."

Glenmark's Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC) is marketed for indications listed in Glenmark's approved drug facts label.

*Nielsen® NIQ Discover; Syndicated Data for Period Ending March 3, 2026

Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is a global, research-led pharmaceutical company with a focus on innovation and accessibility. The company operates 11 manufacturing facilities across four continents and has six research and development centers. Glenmark’s portfolio includes branded, innovative, generics, and consumer health products, with a focus on respiratory, dermatology, and oncology.

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