Omnaris

Treats nasal symptoms associated with seasonal allergic rhinitis. NDA 22004, held by Azurity. Ciclesonide.

As of Nov 13, 2026, NDA 22004 (Omnaris), held by Azurity, was first approved by FDA on Oct 20, 2006, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 20, 2006
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

OMNARIS Nasal Spray is a corticosteroid indicated for treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older and perennial allergic rhinitis in adults and adolescents 12 years of age and older. ( 1.1, 1.2 ) 1.1 Treatment of Seasonal Allergic Rhinitis OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. 1.2 Treatment of Perennial Allergic Rhinitis OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with perennial allergic rhinitis in adults and adolescents 12 years of age and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below


Mar 22, 2013	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 20, 2006	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Omnaris0.05MG/SPRAY · spray, metered;nasal	Ciclesonide	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


May 8, 2019	Supplement 18Labeling · Standard review	Approved	Label Letter
Mar 17, 2016	Supplement 15Labeling	Approved	Letter
Jun 12, 2013	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 22, 2013	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 7, 2010	Supplement 5Labeling · Standard review	Approved	Label Letter
May 7, 2010	Supplement 7Labeling	Approved	Letter
Nov 21, 2007	Supplement 2Labeling · Standard review	Approved	Letter Label
Oct 20, 2006	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 22004
Drugs@FDA: Overview at FDA
Company: Azurity Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters