Glenmark Pharma's RYALTRIS Nasal Spray Approved for Children 6-12 by US FDA

Glenmark Pharmaceuticals Ltd announced that its subsidiary, Glenmark Specialty S.A., has received U.S. FDA approval to expand the use of RYALTRIS® Nasal Spray for children aged 6 to less than 12 years. This approval is for the treatment of symptoms of Seasonal Allergic Rhinitis (SAR). RYALTRIS® is now approved in the U.S. for adults and pediatric patients aged 6 years and older. The approval was based on a Phase 3 study showing improved nasal symptoms compared to placebo in children aged 6 to 11 years. This expansion strengthens Glenmark's respiratory portfolio and its direct commercialization efforts in the U.S. market, following their assumption of end-to-end commercialization responsibilities in April 2026.