Glenmark Gets USFDA Nod for Expanded Use of RYALTRIS Nasal Spray

 Glenmark Pharmaceuticals on Tuesday said it has received approval from the US health regulator for the expanded use of RYALTRIS nasal spray used for the treatment of symptoms of Seasonal Allergic Rhinitis (SAR) in pediatric patients aged 6 to less than 12 years.

Glenmark Specialty SA has received approval from the US Food and Drug Administration for the expanded use of RYALTRIS -- olopatadine hydrochloride and mometasone furoate -- nasal spray of strength 665 mcg/25 mcg per spray, Glenmark Pharmaceuticals said in a regulatory filing.

RYALTRIS is a fixed-dose combination nasal spray that combines olopatadine hydrochloride (an antihistamine) and mometasone furoate (a corticosteroid) in a single formulation.

It was initially approved by the USFDA in 2022 for the treatment of symptoms of SAR in adults and pediatric patients 12 years of age and older, the company said.

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

"This approval marks an important step in expanding access to RYALTRIS in the US by extending its use to children aged 6 to less than 12 years with SAR. It also strengthens the role of RYALTRIS as a key innovative brand within Glenmark's growing US respiratory portfolio," Glenmark President & Business Head, North America, Marc Kikuchi said.

Glenmark has received approvals across key markets, including the European Union, United Kingdom, Australia, South Korea, Russia, and China.

In FY26, it was launched in 11 additional markets, further expanding its global presence to 56 countries, Glenmark added.