Glenmark Pharmaceuticals Limited announced the receipt of U.S. FDA approval for its Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray. The product is bioequivalent and therapeutically equivalent to the reference listed drug, Flonase® Nasal Spray, 0.05 mg/spray of Haleon US Holdings LLC [NDA 020121].
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. This market data includes both brand and all available therapeutic equivalents.
The product will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA. The approval is specifically for the indication(s) listed in Glenmark's approved label, which may differ from the approved reference listed drug indications.
Marc Kikuchi, President & Business Head, North America, commented that this approval "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 stated the company remains "committed to broadening access to quality, affordable treatment options that address the evolving needs of patients and healthcare providers."
The disclosure was made to the National Stock Exchange of India Limited and BSE Limited under reference number 51/26-27, signed by Rashmi Khandelwal, Company Secretary & Compliance Officer (ACS - 28839).