Glenmark Pharmaceuticals has received approval from the U.S. FDA for its Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray. This bioequivalent and therapeutically equivalent alternative to Flonase® Nasal Spray will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA. The approval signifies an expansion of Glenmark’s respiratory product offerings in the American market.
US FDA Approval for Fluticasone Propionate Nasal Spray
Glenmark Pharmaceuticals Limited announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for its Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray. This product is bioequivalent and therapeutically equivalent to the reference listed drug, Flonase® Nasal Spray, 0.05 mg/spray. The nasal spray will be distributed in the United States by Glenmark Pharmaceuticals Inc., USA.
Market Opportunity and Strategic Fit
According to IQVIA® sales data for the 12-month period ending June 2026, the market for Flonase® Nasal Spray achieved annual sales of approximately $295.2 million. Marc Kikuchi, President & Business Head, North America at Glenmark, stated, “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.” He further emphasized the company’s commitment to broadening access to quality, affordable treatment options.
Product Details and Distribution
Glenmark’s Fluticasone Propionate Nasal Spray USP is approved for the indications listed in its approved label. The company aims to make this quality, affordable treatment option available to patients and healthcare providers across the U.S.
Source: BSE
