According to Glenmark, the FDA has approved the company’s sNDA to extend the use of Ryaltris olopatadine / mometasone nasal spray for the treatment of seasonal allergic rhinitis to patients aged 6 -12. Ryaltris was approved for the treatment of seasonal allergic rhinitis in patients aged 12 and over in January 2022. Glenmark recently announced that it will commercialize and distribute Ryaltris in the US, taking over from Hikma.
Glenmark President and Business Head, North America, Marc Kikuchi commented, “This approval marks an important step in expanding access to Ryaltris in the United States by extending its use to children aged 6 to less than 12 years with seasonal allergic rhinitis. It also strengthens the role of Ryaltris as a key innovative brand within Glenmark’s growing US respiratory portfolio.”
Kikuchi added, “Our transition to direct commercialization 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.”
Read the Glenmark press release
