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

NDA 205636
NDA APPROVAL
Teva Pharmaceutical Products R. & D., Inc.
74 NW 176th Street
Miami, FL 33169
Attention:  

William Kiddell,
Associate Director, Respiratory

Dear Mr. Kiddell:
Please refer to your New Drug Application (NDA) dated May 05, 2014, received May 05, 2014,
submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA)
for ProAir RespiClick (albuterol sulfate) powder for inhalation, 90mcg.
We acknowledge receipt of your amendments dated May 23, June 12, and 23, July 28, and 31,
August 08, and 29, November 19, and December 04, 2014, and January 20, and 26, February, 11,
19, 26, and 27, and March 03, 04, 06, 10, 23, and 26, 2015.
The March 06, 2015, submission constituted a complete response to our March 05, 2015, action
letter.
This new drug application provides for the use of ProAir RespiClick (albuterol sulfate) powder
for inhalation for treatment or prevention of bronchospasm in adults and adolescents age 12
years and older, and prevention of exercise induced bronchospasm in adults and adolescents age
12 years 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.
CONTENT OF LABELING
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 package insert). 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

Reference ID: 3723648

 NDA 205636
Page 2

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
Submit final printed carton and immediate container labels that are identical to the enclosed
carton and immediate container labels, as soon as they are available, but no more than 30 days
after they are printed. Please submit these labels electronically according to the guidance for
industry Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical
Product Applications and Related Submissions Using the eCTD Specifications (June 2008).
Alternatively, you may submit 12 paper copies, with 6 of the copies individually mounted on
heavy-weight paper or similar material. For administrative purposes, designate this submission
“Final Printed Carton and Container Labels for approved NDA 205636.” Approval of this
submission by FDA is not required before the labeling is used.
Marketing the product(s) with FPL that is not identical to the approved labeling text may render
the product misbranded and an unapproved new drug.
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 birth to 3 years because necessary
studies are impossible or highly impracticable. This is because of the drug-device delivery.
We are deferring submission of your pediatric studies for ages 4 to 11 years 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 Federal Food, Drug, and
Cosmetic Act/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.
2896-1 

A study to assess the pharmacokinetics of ProAir RespiClick in pediatric asthma
patients between the ages 4 to 11 years.
Final Report Submission:

Reference ID: 3723648

September 30, 2015

 NDA 205636
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2896-2

A study to assess the efficacy and safety of two dose levels of ProAir RespiClick
in pediatric asthma patients between the ages 4 to 11 years.
Final Report Submission:

2896-3

September 30, 2015

A study to assess the chronic dose efficacy and safety of ProAir RespiClick in
pediatric asthma patients between the ages 4 to 11 years.
Final Report Submission:

September 30, 2015

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.
This product is appropriately labeled for use in ages 12 to 17 years for this indication. Therefore,
no additional studies are needed in this pediatric group.
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
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.

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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 Leila P. Hann, Senior Regulatory Project Manager, at (301) 796­
3367.
Sincerely,
{See appended electronic signature page}

Badrul A. Chowdhury, M.D., Ph.D.
Director
Division of Pulmonary, Allergy, and
Rheumatology Products
Office of Drug Evaluation II
Center for Drug Evaluation and Research

Enclosures:
Content of Labeling
Carton and Container Labeling

Reference ID: 3723648

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------BADRUL A CHOWDHURY
03/31/2015

Reference ID: 3723648