Asmanex Twisthaler

Treats asthma as prophylactic therapy. NDA 21067, held by Organon LLC. Mometasone Furoate.

As of Nov 14, 2026, NDA 21067 (Asmanex Twisthaler), held by Organon LLC, was first approved by FDA on Mar 30, 2005, with 9 approved supplements and 0 published complete response letters.

First approved: Mar 30, 2005
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ASMANEX TWISTHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm. ASMANEX TWISTHALER is not indicated in children less than 4 years of age. ASMANEX TWISTHALER is a corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. Limitations of Use: ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm ( 1, 5.2 ) or in children less than 4 years of age ( 1, 8.4 ).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below


Feb 1, 2008	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 30, 2005	Original applicationNew dosage form · Standard review	Approved	Review Letter Label Pediatric Medical Review

Products

2 strengths and forms


Asmanex Twisthaler0.22MG/INH · powder;inhalation	Mometasone Furoate	RxReference drug
Asmanex Twisthaler0.11MG/INH · powder;inhalation	Mometasone Furoate	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


Feb 16, 2021	Supplement 32Labeling · Standard review	Approved	Label Letter
Dec 19, 2019	Supplement 29Labeling · Standard review	Approved	Letter Label
Mar 26, 2018	Supplement 28Labeling · Standard review	Approved	Letter Label
Mar 26, 2018	Supplement 26Labeling · Standard review	Approved	Letter Label
Dec 15, 2016	Supplement 25Manufacturing · Standard review	Approved	None posted
Aug 3, 2015	Supplement 24Manufacturing · Standard review	Approved	None posted
Sep 17, 2010	Supplement 13Labeling · Standard review	Approved	Letter Label
Feb 26, 2008	Supplement 7Labeling · Standard review	Approved	Letter
Feb 1, 2008	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 30, 2005	Original applicationNew dosage form · Standard review	Approved	Review Letter Label Pediatric Medical Review

Identifiers

Application: NDA 21067
Drugs@FDA: Overview at FDA
Company: Organon

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