The U.S. Food and Drug Administration (FDA) has approved Glenmark Pharmaceuticals’ fluticasone propionate nasal spray, USP, 0.05 mg (50 mcg)/spray, a generic version of Haleon's Flonase Nasal Spray indicated for nasal symptoms of allergic rhinitis, the company announced on August 20, 2026.¹
"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," said Marc Kikuchi, President & Business Head, North America, Glenmark Pharmaceuticals. "We remain committed to broadening access to quality, affordable treatment options that address the evolving needs of patients and healthcare providers."¹
Fluticasone Propionate Nasal Spray Approval and Flonase's Regulatory History
Glenmark's fluticasone propionate nasal spray is an intranasal corticosteroid reviewed under the FDA's generic drug pathway, which requires demonstrating comparable pharmacokinetics alongside matching active ingredient, strength, dosage form, and route of administration relative to the reference listed drug.¹ Flonase Nasal Spray was originally approved as a prescription treatment in October 1994, and the FDA cleared its switch to over-the-counter status in July 2014, when it became the first OTC nasal spray indicated for both nasal and eye-related allergy symptoms.² Haleon US Holdings LLC now holds the branded NDA referenced in Glenmark's approval.¹ Glenmark Pharmaceuticals Inc., USA, will distribute the new generic nasal spray.¹
Fluticasone propionate nasal spray treats several symptoms related to allergic rhinitis, including congestion, runny nose, sneezing, itchy nose, and itchy and watery eyes.3 Patients will experience the initial effect in hours and the full effect in days.
Haleon's Flonase Nasal Spray is indicated for patients aged ≥ 12 years and acts on multiple inflammatory substances, including histamine, prostaglandins, cytokines, tryptases, chemokines, and leukotrienes.4 Two randomized, double-blind, placebo-controlled clinical trials have demonstrated that the nasal spray has 24-hour efficacy.4
The company's release did not specify pricing or launch timing.¹ Because the FDA review relied on the bioequivalence pathway rather than an independent clinical program, no new efficacy or safety data accompanies the approval beyond confirming equivalence to Flonase Nasal Spray.¹
References
Glenmark Pharmaceuticals receives U.S. FDA approval for Fluticasone Propionate Nasal Spray, 0.05 mg (50 mcg)/spray. Glenmark Pharmaceuticals. Published August 20, 2026. Accessed August 20, 2026. https://share.google/pRQjggYgtoWuDB8Dy
