– RYALTRIS ® (olopatadine hydrochloride and mometasone furoate nasal spray) treats moderate to severe seasonal allergic rhinitis (SAR) plus associated ocular symptoms in adults, adolescents, and children aged 6 years and older
LAVAL, QC , and MUMBAI, India , Sept. 23, 2022 /CNW Telbec/ – Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC ) (“Bausch Health”) and Glenmark Specialty S. A., a subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark), are pleased to announce that RYALTRIS ® (olopatadine hydrochloride plus mometasone furoate nasal spray) has been approved by Wellness Canada for the symptomatic treatment associated with moderate in order to severe periodic allergic rhinitis (SAR) and associated ocular symptoms within adults, children, and kids aged six years and old. 1
“This Health Europe approval will allow Bausch Health to soon make RYALTRIS available to Canadians, providing an innovative therapy option for seasonal allergic rhinitis, ” Cees Heiman , Senior Vice-President, Europe plus Canada , Bausch Wellness said. “This is part of our ongoing commitment to being a trusted partner in the healthcare of Canadians. ”
RYALTRIS is a fixed-dose combination treatment that provides relief for the symptoms of SAR, both nasal and ocular, in one easy-to-use nose spray. The onset associated with action with regard to nasal symptom relief occurs within 15 minutes after administration of RYALTRIS. 1
“We are very pleased that will Bausch Health, Canada will soon be able to bring the particular benefits of the novel drug RYALTRIS in order to the patients in Nova scotia seeking a new treatment regarding seasonal allergic rhinitis. RYALTRIS is the result associated with our consistent efforts to offer high-quality medicines that benefit individuals around the particular world, and now coming in order to Canada , adding to our own global respiratory leadership, inch said Brendan O’Grady , Chief Executive Officer — Global Formulations Business, Glenmark Pharmaceuticals Ltd.
About RYALTRIS ®
The particular efficacy and safety of RYALTRIS ® were established in a clinical studies program conducted by Glenmark within over 3, 000 sufferers with SAR. Twice-daily RYALTRIS ® provided statistically significant improvement in both nasal plus ocular signs and symptoms vs . placebo, as well as statistically significant onset associated with action in nasal sign relief vs. placebo at 15 minutes, across three randomized, double-blind phase 3 studies (P< 0. 05). RYALTRIS demonstrated a safety profile typical of that observed with intranasal drugs of the same class. one
Important Safety Information intended for Ryaltris ®
RYALTRIS ® is an intra-nasal spray and should not be administered orally, instilled in the eyes, ears or applied to the skin. In 14-day clinical studies of patients with SAR taking RYALTRIS twice a day, the most common adverse events observed were altered taste (3%), nose bleeds (1%) and nasal discomfort (1%). RYALTRIS should not really be used by anyone who has had an
allergic reaction to olopatadine or mometasone or to any ingredient within the formulation or have untreated fungal, bacterial, or tuberculosis infections from the respiratory system tract. Close medical supervision is required in anyone who has a weakened immune system, including those who have had infections with opportunistic pathogens. Increased risk of occurrence or potential worsening associated with pre-existing bacterial infections (e. g. tuberculosis) along with fungi, bacteria or viruses can occur; which includes fatal chickenpox, measles plus herpes infections in susceptible patients. RYALTRIS should be used under close medical supervision in anybody who offers had nose bleeds or even nasal perforation. Recurrence, worsening or persistence of these nose problems can occur. RYALTRIS’ effect on pregnancy and through transmission in breast milk is not known. Talk to your doctor if you are pregnant, plan in order to become pregnant or breastfeeding, to ensure it is safe for you to use. 1
About Bausch Health Companies Inc.
Bausch Health Businesses Inc. (NYSE/TSX: BHC ) is really a global diversified pharmaceutical company whose mission is in order to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our approximately 88. 7% ownership of Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build a modern company dedicated to advancing global health.
About Glenmark Pharmaceuticals Limited.
Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is an innovation-driven worldwide pharmaceutical organization with the presence throughout Specialty, Generics and OTC businesses. It focuses on the particular key therapeutic areas associated with respiratory, dermatology and oncology. The company has 10 world-class manufacturing facilities spread across 4 continents and operations in over 80 countries. Glenmark will be ranked among the world’s top 100 biopharmaceutical companies (Top one hundred Companies Ranked by Pharmaceutical Sales, 2020, by In Vivo/Scrip 100) and among the world’s top 50 businesses in the off-patent sector (Top 50 Generics plus Biosimilars Companies ranked simply by Sales, 2020, by Generics Bulletin/In Vivo). The company was listed on the Dow Jones Sustainability Index (DJSI), one of the world’s most respected and widely accepted sustainability benchmarks, under the category of emerging markets (2021) to get the fourth consecutive year. For more information, visit www.glenmarkpharma.com .
Bausch Wellness, Canada, RYALTRIS ® Product Monograph
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For further information: Bausch Health Businesses: Investor Contact: Christina Cheng, [email protected] , +1 514-856-3855 / +1 877-281-6642 (toll free); Media Contact: Kevin Wiggins, [email protected] , plus one 908-927-1198; Glenmark Pharmaceuticals Limited., Udaykumar Murthy, DGM, Corporate Communications, [email protected] , +91 9960377617