FDA approves Glenmark’s generic fluticasone propionate nasal spray
Glenmark Pharmaceuticals Limited announced on August 20, 2026, that the U.S. Food and Drug Administration approved its generic Fluticasone Propionate Nasal Spray USP, 0.05 mg per spray, for prescription use in the United States. According to Glenmark, the FDA determined the product to be bioequivalent and therapeutically equivalent to the brand-name Flonase Nasal Spray for treating nasal symptoms associated with allergic rhinitis.
The approval covers a prescription metered nasal spray formulation indicated for the treatment of nasal symptoms associated with allergic rhinitis, including seasonal and perennial forms, officials said. The agency determined the product to be bioequivalent and therapeutically equivalent to the reference listed drug under an Abbreviated New Drug Application (ANDA), as confirmed by DailyMed labeling and marketing status records.
The FDA approved Glenmark’s Fluticasone Propionate Nasal Spray USP, 0.05 mg per spray, as a generic equivalent to Haleon US Holdings LLC’s Flonase Nasal Spray, according to Glenmark Pharmaceuticals Limited’s announcement on August 20, 2026.
The approved generic delivers 50 micrograms of fluticasone propionate per 100-milligram spray, consistent with the dosing strength of Flonase Nasal Spray, according to DailyMed drug information. The nasal spray is intended for local intranasal administration and is formulated to minimize systemic glucocorticoid exposure relative to oral corticosteroids, officials noted. Fluticasone propionate is classified pharmacologically as a glucocorticoid corticosteroid and is commonly used once or twice daily for intranasal corticosteroid therapy, although specific dosing schedules are determined by the approved product label.
Glenmark’s approval expands its portfolio of U.S. generic corticosteroid nasal sprays, adding a technically demanding dosage form to its ANDA pipeline, industry sources said. The company had previously received final FDA approval for an over-the-counter (OTC) fluticasone propionate nasal spray USP, 50 mcg per spray, on March 19, 2026. That OTC product, marketed as bioequivalent to Flonase Allergy Relief, is associated with ANDA 218742 and is distributed in the United States by Glenmark Therapeutics Inc., USA, according to company communications and DailyMed records.
The newly approved prescription spray competes in a market where Flonase has been a leading brand for nasal corticosteroids. Glenmark emphasized in its public statements that the FDA’s determination of bioequivalence and therapeutic equivalence strengthens its position in the U.S. generics market. Glenmark’s broader respiratory portfolio also includes other fluticasone propionate generics, such as the FDA-approved generic of Flovent HFA inhalation aerosol 44 mcg per actuation, which received competitive generic therapy exclusivity in March 2026.
The FDA approval documentation and Glenmark’s press materials confirm that the product is non-controlled and carries no DEA schedule. The nasal spray is indicated for nasal symptoms of allergic rhinitis and perennial nonallergic rhinitis in adults and pediatric patients aged 4 years and older, consistent with standard fluticasone propionate nasal spray labeling found on DailyMed. These indications include relief from runny nose, nasal congestion, sneezing, and nasal itching.
Trade and healthcare media outlets reported Glenmark’s August 20 announcement as the company “getting FDA nod” for the generic fluticasone propionate nasal spray. Glenmark’s North America unit reiterated the FDA approval on LinkedIn, noting distribution plans for the OTC product through Glenmark Therapeutics Inc., USA. Regulatory data also show international activity around fluticasone propionate nasal sprays, including a product branded as Flusort approved by the Philippines FDA in March 2025, although this is unrelated to the U.S. generic approval.
The FDA’s approval of Glenmark’s generic fluticasone propionate nasal spray under the ANDA pathway reflects ongoing regulatory processes to expand access to generic corticosteroid nasal sprays in the U.S. market. Glenmark’s announcement followed established protocols for generic drug approvals, including demonstration of bioequivalence and therapeutic equivalence to the reference listed drug. The company’s expanding ANDA portfolio underscores its focus on inhaled and nasal steroid platforms within the respiratory therapeutic area.
