In an official filing submitted to the stock exchanges, Glenmark Pharmaceuticals Limited announced that it has received final approval from the United States Food and Drug Administration (U.S. FDA) for Fluticasone Propionate Nasal Spray USP, 0.05 mg (50 mcg)/spray.
According to the regulatory disclosure, the newly approved nasal spray is bioequivalent and therapeutically equivalent to the reference listed drug Flonase Nasal Spray (0.05 mg/spray) of Haleon US Holdings LLC. The product will be commercialized and distributed across the U.S. market by Glenmark Pharmaceuticals Inc., USA.
Market data from IQVIA for the twelve months ending June 2026 highlights that the broader Flonase Nasal Spray market achieved annual sales of approximately $295.2 million, signaling a strong commercial opportunity for Glenmark’s generic alternative.
Commenting on the milestone, Marc Kikuchi, President and Business Head for North America at Glenmark, stated that the approval marks another important step in expanding their respiratory portfolio in the U.S. and building upon their established foundation in the therapeutic area, reinforcing their commitment to broadening access to quality, affordable treatment options.
Glenmark Pharmaceuticals continues to cement its global footprint as a research-led pharmaceutical leader with a strong strategic focus on respiratory care, dermatology, and oncology across major international markets. Investors tracking the stock can note the BSE Scrip Code: 532296 and NSE Symbol: GLENMARK, with the company operating under ISIN INE935A01035.
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