Glenmark Pharmaceuticals Limited has announced that it has received final approval from the United States Food & Drug Administration (U.S. FDA) for its Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC). The nasal spray has been determined by the FDA to be bioequivalent to the reference listed drug, Flonase® Allergy Relief Nasal Spray, 50 mcg per spray, of Haleon US Holding LLC. The product 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 market for Flonase® Allergy Relief Nasal Spray, 50 mcg per spray, achieved annual sales of approximately $384.7 million. Marc Kikuchi, President & Business Head, North America, expressed excitement over the approval, stating that it marks the first approved nasal spray distributed by Glenmark Therapeutics Inc., USA in the OTC space. The company plans to launch the product in April 2026.
The Fluticasone Propionate Nasal Spray is marketed only for the indications listed in Glenmark’s approved drug facts label. It is important to note that this product is not manufactured or distributed by Haleon and/or GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) IP LIMITED, the distributor of FLONASE® Allergy Relief and owner of the registered trademark FLONASE®.
Glenmark Pharmaceuticals is a global, research-led pharmaceutical company focused on innovation and accessibility. The company has a commercial footprint in over 80 countries and delivers a diversified portfolio across branded, innovative, generics, and consumer health products, with a focus on respiratory, dermatology, and oncology.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).