Glenmark Gets USFDA Nod for Generic Fluticasone Nasal Spray, Targets USD 295 Mn Market

New Delhi: Glenmark Pharmaceuticals Limited (Glenmark) has announced the receipt of U.S. FDA approval 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® 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. Glenmark’s Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray is only approved for the indication(s) listed in Glenmark’s approved label.

According to IQVIA® sales data for the 12-month period ending June 2026, the Flonase® Nasal Spray market 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.”