DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993
NDA 22212/S-011
SUPPLEMENT APPROVAL
FULFILLMENT OF POSTMARKETING REQUIREMENT
Alcon Pharmaceuticals Ltd.
c/o Alcon Research Ltd.
Attention: C. Brad Wooldridge, M.S.
Director, Regulatory Affairs
6201 South Freeway, R3-52
Fort Worth, Texas 76134-2099
Dear Mr. Wooldridge:
Please refer to your Supplemental New Drug Application (sNDA) dated and received
September 25, 2012, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
Act (FDCA) for Durezol (difluprednate ophthalmic emulsion) 0.05%.
We acknowledge receipt of your amendments dated October 15, and December 6 and 12, 2012,
and March 8 and 19, 2013.
This “Prior Approval” supplemental new drug application provides for revisions to the Pediatric
Use section of the package insert to reflect the results from Clinical Study C-10-004 entitled, “A
Phase 3B, Multicenter, Randomized, Double-Masked, Parallel-Group, Active-Controlled Study
of the Safety and Efficacy of Difluprednate Ophthalmic Emulsion, 0.05% (Durezol) 4 Times
Daily (QID) and Prednisolone Acetate Ophthalmic Suspension, 1.0% (Pred Forte) QID for the
Treatment of Inflammation Following Cataract Surgery in Children 0 to 3 Years of Age.
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 and with the minor editorial revision listed below and included in the enclosed labeling:
For each Recent Major Change listed in the Highlights, please mark the corresponding
new or modified text in the Full Prescribing Information with a vertical line (“margin
mark”) on the left edge.
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
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NDA 22212/S-011
Page 2
of labeling must be identical to the enclosed text for the package insert, 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
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 marked-
up 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).
FULFILLMENT OF POSTMARKETING REQUIREMENT
We note that this supplemental application contains the final report for the following
postmarketing requirement listed in the June 23, 2008, approval letter.
1444-1 A study of pediatric patients 0 to 3 years of age for the treatment of post-operative
inflammation following cataract surgery
We have reviewed your submission and conclude that the above requirement was fulfilled.
This completes all of your postmarketing requirements acknowledged in our June 23, 2008,
letter.
PROMOTIONAL MATERIALS
You may request advisory comments on proposed introductory advertising and promotional
labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
comments, (2) the proposed materials in draft or mock-up form with annotated references, and
(3) the package insert(s) to:
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Prescription Drug Promotion (OPDP)
5901-B Ammendale Road
Beltsville, MD 20705-1266
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NDA 22212/S-011
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You must submit final promotional materials and package insert, accompanied by a Form FDA
2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form FDA
2253 is available at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html; instructions
are provided on page 2 of the form. 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 Michael Puglisi, Regulatory Project Manager, at (301) 796-0791.
Sincerely,
{See appended electronic signature page}
Wiley A. Chambers, M.D.
Deputy Director
Division of Transplant and Ophthalmology Products
Office of Antimicrobial Products
Center for Drug Evaluation and Research
ENCLOSURES:
Content of Labeling
Reference ID: 3281174
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This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
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/s/
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WILEY A CHAMBERS
03/22/2013
Reference ID: 3281174
