Glenmark Pharmaceuticals has received final U.S. FDA approval for its Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC). The product is bioequivalent to the reference listed drug, Flonase® Allergy Relief Nasal Spray. The spray will be distributed in the U.S. by Glenmark Therapeutics Inc., USA, with a planned launch in April 2026. The comparable market achieved annual sales of approximately $384.7 million in the latest reporting period.
FDA Approval Secured for OTC Nasal Spray
Glenmark Pharmaceuticals Limited announced on March 19, 2026, that its U.S. subsidiary has secured final approval from the United States Food & Drug Administration (U.S. FDA) for its Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC). This approval marks a significant step for Glenmark into the Over-The-Counter (OTC) space in the U.S. market.
Bioequivalence and Reference Drug
The newly approved product has been determined by the FDA to be bioequivalent to the reference listed drug, Flonase® Allergy Relief Nasal Spray, 50 mcg per spray, which is marketed by Haleon US Holding LLC (NDA – 205434). The Glenmark product will be distributed across the U.S. via Glenmark Therapeutics Inc., USA.
Market Opportunity and Launch Plan
According to Nielsen® syndicated data for the 52-week period ending March 3, 2026, the market for the reference drug achieved annual sales of approximately $384.7 million. Marc Kikuchi, President & Business Head, North America, stated that the company is excited to launch this quality over-the-counter solution, with plans to bring the product to customers in April 2026.
About Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. is a global, research-led pharmaceutical company focused on innovation and accessibility. The company supports its operations with 11 world-class manufacturing facilities across four continents and a commercial footprint in 80+ countries. The company maintains a diversified portfolio across branded, innovative, generics, and consumer health products, with strategic focus areas in respiratory, dermatology, and oncology.
Source: BSE
