Glenmark Pharmaceuticals Ltd has received approval from the US Food and Drug Administration (US FDA) for Fluticasone Propionate Nasal Spray USP, 0.05 mg (50 mcg)/spray, strengthening its respiratory portfolio in the US market.
The company said its Fluticasone Propionate Nasal Spray is bioequivalent and therapeutically equivalent to Flonase Nasal Spray, 0.05 mg/spray, the reference listed drug of Haleon US Holdings LLC.
The product will be distributed in the US by Glenmark Pharmaceuticals Inc., USA.
According to IQVIA sales data for the 12-month period ended June 2026, the US Flonase Nasal Spray market recorded annual sales of approximately $295.2 million.
Expands respiratory portfolio
Glenmark Pharmaceuticals President & Business Head, North America, Marc Kikuchi, said the approval marks another step in expanding the company’s respiratory portfolio in the US.
“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,” Kikuchi said.
He added that Glenmark remains focused on broadening access to quality and affordable treatment options to address the evolving needs of patients and healthcare providers.
The latest approval further strengthens Glenmark’s presence in the US respiratory segment, where the company has been expanding its portfolio of generic and specialty pharmaceutical products.