Glenmark Pharmaceuticals on Friday announced approval by Health Canada for its nasal spray Ryaltris used in symptomatic treatment of moderate to severe seasonal allergic rhinitis and associated ocular symptoms.
Health Canada granted approval to partner Bausch Health Companies Inc and Glenmark Specialty SA, a subsidiary of the company, for Ryaltris (olopatadine hydrochloride and mometasone furoate nasal spray), Glenmark Pharmaceuticals said in a statement.
"This Health Canada approval will allow Bausch Health to soon make Ryaltris available to Canadians, providing an innovative therapy option for seasonal allergic rhinitis," Bausch Health Senior Vice-President, Europe and Canada, Cees Heiman said.
Ryaltris is a fixed-dose combination therapy that provides relief from the symptoms of SAR, both nasal and ocular, in one easy-to-use nasal spray.
The approval granted by Health Canada is for the usage of Ryaltris for the symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults, adolescents, and children aged 6 years and older, the statement said.
"Ryaltris is a result of our consistent efforts to offer high-quality medicines that benefit patients around the world, and now coming to Canada, adding to our global respiratory leadership," Glenmark Pharmaceuticals Ltd CEO, Global Formulations Business, Brendan O'Grady said.Glenmark said the efficacy and safety of Ryaltris were established in a clinical studies conducted by it in over 3,000 patients with SAR.