FDA Expands Pediatric Allergy Nasal Spray Use - Takeaways - MDSpire

FDA Expands Pediatric Allergy Nasal Spray Use

A phase 3 randomized, double-blind, placebo-controlled trial in pediatric patients demonstrated improved nasal symptoms compared with placebo.

  • By

  • Kathryn Wighton

  • July 22, 2026

  • 2 min

Share

  • 1

    The FDA has expanded the indication for RYALTRIS nasal spray to include children aged 6 to under 12 years with seasonal allergic rhinitis.

  • 2

    The approval was based on a phase 3 trial with 446 pediatric patients showing greater improvement in nasal symptoms compared to placebo.

  • 3

    RYALTRIS is a fixed-dose combination nasal spray containing olopatadine hydrochloride and mometasone furoate.

  • 4

    The product was initially approved in 2022 for adults and children aged 12 years and older.

  • 5

    Common adverse reactions include dysgeusia, epistaxis, and nasal discomfort, with warnings for various serious conditions.

Original Source(s)

FDA Expands Pediatric Allergy Nasal Spray Use

  • by Kathryn Wighton

  • July 22, 2026

Related Content

AD Not Linked to Early CV Risk Markers

Repeated assessments from childhood to early adulthood did not identify consistent cardiometabolic risk patterns by disease activity or severity.

Beta-2 Agonists Tied to ASD Risk?

Systematic review of 8 observational studies found limited evidence on associations between prenatal asthma-medication exposure and neurodevelopmental outcomes, with autism spectrum disorder the only outcome suitable for meta-analysis.

Youth Vaping Is "Predictable" by Design

Product engineering, not individual choice, is driving adolescent nicotine dependence, researchers argue.