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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 203567/S-006
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`Food and Drug Administration
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` Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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` Dow Pharmaceutical Sciences, Inc.
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` Attention: Sean Humphrey
` Sr. Manager, Regulatory Affairs
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` 1330 Redwood Way, Suite C
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` Petaluma, CA 94954
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`Dear Mr. Humphrey:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received April 13,
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`2016, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for Jublia (efinaconazole) solution, 10%.
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`This “Changes Being Effected” supplemental new drug application proposes the following
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`change(s): wording revision to Step 2, 3 and 4 of the Instruction for Use labeling.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
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`text.
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`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
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling (text for the Instructions for Use), with the
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`addition of any labeling changes in pending “Changes Being Effected” (CBE) supplements, as
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`well as annual reportable changes not included in the enclosed labeling.
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`Information on submitting SPL files using eList may be found in the guidance for industry titled
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`“SPL Standard for Content of Labeling Technical Qs and As at
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
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`The SPL will be accessible from publicly available labeling repositories.
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`Reference ID: 3988691
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` NDA 203567/S-006
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` Page 2
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` Also within 14 days, amend all pending supplemental applications that include labeling changes
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` for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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` with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
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` changes approved in this supplemental application, as well as annual reportable changes and
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` annotate each change. To facilitate review of your submission, provide a highlighted or marked-
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` up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
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` should provide appropriate annotations, including supplement number(s) and annual report
`date(s).
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Strother D. Dixon, Senior Regulatory Project Manager, at (301)
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`796-1015.
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`Sincerely,
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`{See appended electronic signature page}
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`Jill Lindstrom, MD, FAAD
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`Deputy Director
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`Division of Dermatology and Dental Products
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`Office of Drug Evaluation III
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`Center for Drug Evaluation and Research
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`ENCLOSURE:
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`Content of Labeling
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`Reference ID: 3988691
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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.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`JILL A LINDSTROM
`09/22/2016
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`Reference ID: 3988691
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