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Ryaltris FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 20, 2022.

FDA Approved: Yes (First approved January 13, 2022)
Brand name: Ryaltris
Generic name: mometasone furoate and olopatadine hydrochloride
Dosage form: Nasal Spray
Company: Glenmark Pharmaceuticals Inc.
Treatment for: Allergic Rhinitis

Ryaltris (mometasone and olopatadine) nasal spray is a corticosteroid and antihistamine combination for the treatment of seasonal allergic rhinitis (SAR) in patients 12 years of age and older.

  • The corticosteroid and antihistamine ingredients in Ryaltris work together to reduce nasal inflammation associated with seasonal allergic rhinitis.
  • Ryaltris is administered as two sprays in each nostril twice daily.
  • Common adverse reactions include dysgeusia, epistaxis, and nasal discomfort.

Development timeline for Ryaltris

Jan 14, 2022Approval FDA Approves Ryaltris (mometasone and olopatadine) Nasal Spray for Seasonal Allergic Rhinitis
Jun 25, 2019FDA Issues Complete Response Letter for Ryaltris NDA
Feb 25, 2019Glenmark Pharmaceuticals Announces Results from New Analysis of Pooled Data on Ryaltris™, an Investigational Product for the Treatment of Seasonal Allergic Rhinitis, at the AAAAI 2019 Annual Meeting
Nov 15, 2018Glenmark Pharmaceuticals Announces New Data Presentations on Ryaltris at the ACAAI Annual Scientific Meeting 2018
May 21, 2018Glenmark Pharmaceuticals Announces the Company's First NDA for Ryaltris for Patients with Seasonal Allergic Rhinitis

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.