Asmanex Hfa

Treats asthma as prophylactic therapy. NDA 205641, held by Organon LLC. Mometasone Furoate.

As of Nov 15, 2026, NDA 205641 (Asmanex Hfa), held by Organon LLC, was first approved by FDA on Apr 25, 2014, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 25, 2014
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ASMANEX HFA is a corticosteroid indicated for: Maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Important limitations: Not indicated for the relief of acute bronchospasm. 1.1 Treatment of Asthma ASMANEX HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Important Limitations of Use ASMANEX HFA is NOT indicated for the relief of acute bronchospasm.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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


Aug 12, 2019	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 12, 2016	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review
Apr 25, 2014	Original applicationTYPE 2/3 · Standard review	Approved	Review Summary Review Label Letter

Products

3 strengths and forms


Asmanex Hfa0.10MG/INH · aerosol, metered;inhalation	Mometasone Furoate	RxReference drug
Asmanex Hfa0.20MG/INH · aerosol, metered;inhalation	Mometasone Furoate	RxReference drug
Asmanex Hfa0.05MG/INH · aerosol, metered;inhalation	Mometasone Furoate	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Aug 12, 2019	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 26, 2018	Supplement 7Labeling · Standard review	Approved	Letter Label
Mar 26, 2018	Supplement 8Labeling · Standard review	Approved	Letter Label
Jul 12, 2016	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review
Aug 6, 2015	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 3, 2015	Supplement 4Manufacturing	Approved	Label
Jun 16, 2015	Supplement 2Labeling · Standard review	Approved	Label Letter
Apr 25, 2014	Original applicationTYPE 2/3 · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 205641
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