DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993

NDA 205641
NDA APPROVAL
Merck Sharp & Dohme Corp.
One Merck Drive
P.O. Box 100
Whitehouse Station, NJ 08889
Attention:

Scott Hambaugh
Director, Regulatory Liaison
Global Regulatory Affairs

Dear Mr. Hambaugh:
Please refer to your New Drug Application (NDA) dated June 27, 2013, received June 27, 2013,
submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
Asmanex HFA (mometasone furoate) Inhalation Aerosol 100 mcg and 200 mcg.
We acknowledge receipt of your amendments dated September 4, 12, and 19, October 22, 2013,
and January 28, April 4, and 17 (2), 18, and 22, 2014.
This new drug application provides for the use of Asmanex HFA for maintenance treatment of
asthma as prophylactic therapy in patients 12 years of age and older.
We have completed our review of this application, as amended. It is approved, effective on the
date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
EXPIRATION DATING PERIOD
A 36-month expiry dating period is granted for Asmanex HFA (mometasone furoate) when
stored at controlled room temperature between 20°C and 25°C (68°F and 77°F) with excursions
permitted from 15°C and 30°C (59°F and 86°F).
WAIVER OF HIGHLIGHTS SECTION
We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of
prescribing information. This waiver applies to all future supplements containing revised
labeling unless we notify you otherwise.
CONTENT OF LABELING

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As soon as possible, but no later than 14 days from the date of this letter, submit the content of
labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
automated drug registration and listing system (eLIST), as described at
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
of labeling must be identical to the enclosed labeling (text for the Package Insert, text for the
Patient Information Leaflet, Instructions for Use). Information on submitting SPL files using
eLIST may be found in the guidance for industry SPL Standard for Content of Labeling
Technical Qs and As, available at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
CM072392.pdf.
The SPL will be accessible via publicly available labeling repositories.
CARTON AND IMMEDIATE CONTAINER LABELS
We acknowledge your April 4, 2014, submission containing final printed carton and container
labels.
REQUIRED PEDIATRIC ASSESSMENTS
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
administration are required to contain an assessment of the safety and effectiveness of the
product for the claimed indication(s) in pediatric patients unless this requirement is waived,
deferred, or inapplicable.
We are waiving the pediatric studies requirement for ages 0 through 4 years of age because the
product does not represent a meaningful therapeutic benefit over existing therapies for pediatric
patients in this age group and is not likely to be used in a substantial number of pediatric patients
in this group.
We are deferring submission of your pediatric studies for ages 5 through 11 years of age for this
application because this product is ready for approval for use in adults and the pediatric study
have not been completed.
Your deferred pediatric studies required by section 505B(a) of the FDCA are required
postmarketing studies. The status of these postmarketing studies must be reported annually
according to 21 CFR 314.81 and section 505B(a)(3)(B) of the Federal Food, Drug, and Cosmetic
Act/FDCA. These required studies are listed below.
2149-1  

A 12-week, randomized, placebo-controlled, dose-ranging efficacy and
safety study of mometasone furoate metered dose inhaler (MDI) in the
treatment of children ages 5-11 years with persistent asthma.
Study Completion:
Final Report Submission:

Reference ID: 3496092

04/2015
09/2015

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2149-2  

A 12-week, double-blind, active-controlled, efficacy and safety study of
two doses of mometasone furoate/formoterol fumarate combination MDI
compared with the corresponding doses of mometasone furoate
monotherapy MDI in the treatment of children ages 5-11 with persistent
asthma.
Final Protocol Submission:
Study Completion:
Final Report Submission:

2149-3  

10/2015
09/2018
02/2019

A 6-month safety study, with a 6-month extension of two doses of
mometasone furoate/formoterol fumarate combination MDI compared to
fluticasone/salmeterol combination DPI in children 5-11 years of age with
persistent asthma.
Final Protocol Submission:
Study Completion:
Final Report Submission:

10/2015
09/2018
02/2019

Submit the protocols to your INDs 70,283 and 112,669, with a cross-reference letter to this
NDA.
Reports of these required pediatric postmarketing studies must be submitted as a new drug
application (NDA) or as a supplement to your approved NDA with the proposed labeling
changes you believe are warranted based on the data derived from these studies. When
submitting the reports, please clearly mark your submission "SUBMISSION OF REQUIRED
PEDIATRIC ASSESSMENTS" in large font, bolded type at the beginning of the cover letter of
the submission.
We note that you have fulfilled the pediatric studies requirement for ages 12 to 18 years for this
application.
PROMOTIONAL MATERIALS
You may request advisory comments on proposed introductory advertising and promotional
labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
proposed materials in draft or mock-up form with annotated references, and the package insert
to:
Food and Drug Administration 

Center for Drug Evaluation and Research 

Office of Prescription Drug Promotion 

5901-B Ammendale Road 

Beltsville, MD 20705-1266 


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As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
package insert, at the time of initial dissemination or publication, accompanied by a Form FDA
2253. Form FDA 2253 is available at
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
Information and Instructions for completing the form can be found at
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
more information about submission of promotional materials to the Office of Prescription Drug
Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
REPORTING REQUIREMENTS
We remind you that you must comply with reporting requirements for an approved NDA
(21 CFR 314.80 and 314.81).
If you have any questions, call Jessica Lee, Regulatory Project Manager, at (301) 796-3769.
Sincerely,
{See appended electronic signature page}

Lydia Gilbert-McClain, MD
Deputy Director
Division of Pulmonary, Allergy, and
Rheumatology Products
Office of Drug Evaluation II
Center for Drug Evaluation and Research

Enclosure(s):
Content of Labeling
Carton and Container Labeling

Reference ID: 3496092

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------LYDIA I GILBERT MCCLAIN
04/25/2014

Reference ID: 3496092