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Pharmaceuticals
USFDA20 Aug 2026, 08:54 am

Glenmark Pharma Gets US FDA Nod for Fluticasone Propionate Nasal Spray

AI Summary

Glenmark Pharmaceuticals Limited has received U.S. FDA approval for its Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray. This product is bioequivalent and therapeutically equivalent to Flonase® Nasal Spray, 0.05 mg/spray, a reference drug by Haleon US Holdings LLC. The nasal spray will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA. The market for Flonase® Nasal Spray achieved approximately $295.2 million in annual sales for the 12 months ending June 2026, according to IQVIA® sales data. This approval signifies an expansion of Glenmark's respiratory portfolio in the U.S., aiming to provide affordable treatment options.

Key Highlights

  • US FDA approval received for Fluticasone Propionate Nasal Spray.
  • Product is bioequivalent to Flonase® Nasal Spray.
  • Targeting the US market with an estimated $295.2 million annual sales.
  • Expands Glenmark's respiratory product portfolio in the US.
  • Aims to offer affordable and quality treatment options.