Glenmark Pharma’s arm gets USFDA’s nod to expand use of RYALTRIS Nasal Spray

Glenmark Pharmaceuticals’ wholly-owned subsidiary -- Glenmark Specialty S.A. (Glenmark) has received USFDA's approval to expand use of RYALTRIS (olopatadine hydrochloride and mometasone furoate) Nasal Spray, 665 mcg/25 mcg per spray, for the treatment of symptoms of Seasonal Allergic Rhinitis (SAR) in pediatric patients aged 6 to less than 12 years.

With this approval, RYALTRIS is now approved in the United States for adults and pediatric patients aged 6 years and older, extending this treatment option to a younger pediatric population.

The approval was supported by a Phase 3, randomized, double-blind, placebo-controlled study involving 446 children aged 6 to 11 years with Seasonal Allergic Rhinitis. The study demonstrated that RYALTRIS improved nasal symptoms compared with placebo and was well tolerated over the 14-day treatment period.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.