Glenmark Pharmaceuticals Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluticasone Propionate Nasal Spray USP, 0.05 mg (50 mcg)/spray.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Flonase® Nasal Spray, 0.05 mg/spray, by Haleon US Holdings LLC. The product will be commercialized and distributed across the United States by Glenmark Pharmaceuticals Inc., USA.
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 (including brand and available therapeutic equivalents).
”The approval of Fluticasone Propionate Nasal Spray USP 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,” said Marc Kikuchi, President & Business Head, North America. “We remain committed to broadening access to quality, affordable treatment options that address the evolving needs of patients and healthcare providers.”
The approval reinforces Glenmark’s continuous focus on expanding its core respiratory pipeline and delivering affordable, high-quality generic therapeutics to the U.S. market.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
