Glenmark Pharmaceuticals Limited has received U.S. FDA approval for Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray, further expanding its respiratory medicine portfolio in the United States. Glenmark Pharmaceuticals Inc., USA will distribute the product in the U.S. market. The approved nasal spray is bioequivalent and therapeutically equivalent to Flonase® Nasal Spray, 0.05 mg/spray, the reference listed drug marketed by Haleon US Holdings LLC under NDA 020121.
Fluticasone Nasal Spray Targets a $295 Million Market
The approval gives Glenmark access to an established U.S. nasal spray market. According to IQVIA® sales data for the 12-month period ending June 2026, Flonase® Nasal Spray recorded annual sales of approximately $295.2 million in the United States. Therefore, the approval provides Glenmark with an opportunity to strengthen its presence in the U.S. respiratory segment and expand access to an established treatment option.
Glenmark Strengthens Respiratory Portfolio
Marc Kikuchi, President & Business Head, North America, Glenmark, said the approval represents another step in expanding the company’s U.S. respiratory portfolio. He added that the company has established a strong foundation in the therapeutic area and remains focused on broadening access to quality and affordable treatment options that address the evolving needs of patients and healthcare providers.
U.S. Approval Supports Glenmark’s Growth Strategy
The latest U.S. FDA approval further strengthens Glenmark’s respiratory product portfolio and supports its broader strategy of expanding affordable pharmaceutical options in key international markets. As per the press release, with the Fluticasone Propionate Nasal Spray now approved for the U.S. market, Glenmark continues to build its presence in respiratory healthcare while leveraging its portfolio of differentiated and accessible pharmaceutical products.
