Glenmark Specialty SA (Glenmark) said it has received approval from the US Food and Drug Administration for the expanded use of Ryaltris nasal spray, to treat seasonal allergic rhinitis (SAR) symptoms, in paediatric patients aged 6 to less than 12 years.With this approval, Ryaltris (olopatadine hydrochloride and mometasone furoate nasal spray) is approved in the US for adults and paediatric patients aged 6 years and older, it said.The approval was supported by a Phase III, randomised, double-blind, placebo-controlled study involving 446 children aged 6 to 11 years with SAR. It demonstrated that Ryaltris improved nasal symptoms compared with placebo and was well tolerated over the 14-day treatment period, the company said.“Seasonal allergies are common among school-age children in the US. According to the US Centers for Disease Control and Prevention, 25 per cent of children aged 6 to 11 years had a diagnosed seasonal allergy in 2024. Seasonal allergic rhinitis (SAR) affects far more than nasal symptoms, significantly impacting children’s overall health, emotional well-being, sleep, and participation in physical activity, with potential long-term consequences for healthy development and obesity risk,” the company note added.Marc Kikuchi, Glenmark President and Business Head, North America, said the approval also strengthens the role of Ryaltris as a key innovative brand within Glenmark’s growing US respiratory portfolio. “Our transition to direct commercialisation gives us greater ownership of the brand and enables closer engagement with healthcare professionals and patients. We intend to use this platform to expand access, build the Ryaltris franchise and further strengthen Glenmark’s innovation-led presence in the US specialty market,” he added. From April 1, 2026, Glenmark Pharmaceuticals Inc has been handling the commercialisation and distribution of Ryaltris in the US, it said.Published on July 21, 2026