DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
Silver Spring MD 20993

NDA 205636/S-004
SUPPLEMENT APPROVAL
FULFILLMENT OF POSTMAREKETING REQUIREMENT

Teva Branded Pharmaceutical Products R&D, Inc.
41 Moores Road
Frazer, PA 19355
Attention:  

Michael J. McGraw, PharmD, MS
Senior Director, Regulatory Affairs

Dear Dr. McGraw:
Please refer to your Supplemental New Drug Application (sNDA) dated June 29, 2015, received
June 29, 2015, and your amendments, submitted pursuant to section 505(b)(2) of the Federal
Food, Drug, and Cosmetic Act (FDCA) for ProAir RespiClick (albuterol sulfate), powder for
inhalation, 90 mcg.
This Prior Approval supplemental new drug application provides for the extension of the
indications to include 4-11 year old patients.
APPROVAL & LABELING
We have completed our review of this supplemental 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(PI) and text for
the patient package insert (PPI), with the addition of any labeling changes in pending “Changes
Being Effected” (CBE) supplements, as well as annual reportable changes not included in the
enclosed labeling.
Information on submitting SPL files using eList may be found in the guidance for industry titled
“SPL Standard for Content of Labeling Technical Qs and As at

Reference ID: 3923682

 NDA 205636/S-004
Page 2

http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
CM072392.pdf
The SPL will be accessible from publicly available labeling repositories.
Also within 14 days, amend all pending supplemental applications that includes labeling changes
for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
changes approved in this supplemental application, as well as annual reportable changes and
annotate each change. To facilitate review of your submission, provide a highlighted or markedup copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
should provide appropriate annotations, including supplement number(s) and annual report
date(s).
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.
Because none of these criteria apply to your application, you are exempt from this requirement.
FULFILLMENT OF POSTMARKETING REQUIREMENTS
We have received your submission dated June 29, 2015, containing the final report for the
following postmarketing requirements listed in the March 31, 2015 approval letter.
2896-1   Conduct a study to assess the pharmacokinetics of ProAir RespiClick in
pediatric asthma patients between the ages 4 to 11 years.
2896-2   Conduct 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.
2896-3   Conduct a study to assess the chronic dose efficacy and safety of ProAir
RespiClick in pediatric asthma patients between the ages 4 to 11 years.
We have reviewed your submission and conclude that the above requirements were fulfilled.
This completes all of your postmarketing requirements acknowledged in our March 31, 2015
letter.
REPORTING REQUIREMENTS
We remind you that you must comply with reporting requirements for an approved NDA
(21 CFR 314.80 and 314.81).

Reference ID: 3923682

 NDA 205636/S-004
Page 3

If you have any questions, call Carol F. Hill, Senior Regulatory Health Project Manager for
Safety, at (301) 796-1226.
Sincerely,
{See appended electronic signature page}
Sally Seymour, MD
Deputy Director for Safety
Division of Pulmonary, Allergy, and Rheumatology
Products
Office of Drug Evaluation II
Center for Drug Evaluation and Research
ENCLOSURE:
Content of Labeling

Reference ID: 3923682

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------SALLY M SEYMOUR
04/28/2016

Reference ID: 3923682