Alvesco

Treats asthma as prophylactic therapy. NDA 21658, held by Azurity. Ciclesonide.

As of Nov 14, 2026, NDA 21658 (Alvesco), held by Azurity, was first approved by FDA on Jan 10, 2008, with 7 approved supplements and 0 published complete response letters.

First approved: Jan 10, 2008
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. Limitations of Use: ALVESCO is not indicated for the relief of acute bronchospasm. ALVESCO is not indicated for children under 12 years of age. ALVESCO is an inhaled corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. Limitations of Use: ALVESCO is not indicated for the relief of acute bronchospasm or in pediatric patients less than 12 years of age.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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


Dec 17, 2012	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 10, 2008	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Products

2 strengths and forms


Alvesco0.08MG/INH · aerosol, metered;inhalation	Ciclesonide	RxReference drug
Alvesco0.16MG/INH · aerosol, metered;inhalation	Ciclesonide	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Feb 16, 2023	Supplement 11Labeling · Standard review	Approved	Letter Label
Apr 22, 2014	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 7, 2013	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 17, 2012	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 19, 2012	Supplement 5Labeling	Approved	Label Letter
Dec 22, 2008	Supplement 2Labeling · Standard review	Approved	Label Letter
Oct 10, 2008	Supplement 1Manufacturing	Approved	None posted
Jan 10, 2008	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 21658
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