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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 203567/S-002
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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
` Attention: Sean Humphrey
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` Manager, Regulatory Affairs
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` 1330 Redwood Way
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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 July 23, 2014 received
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`on July 23, 2014, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
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`(FDCA) for Jublia (efinaconazole) topical solution, 10%.
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`We acknowledge receipt of your amendments dated December 15, 2014 and February 5, 2015.
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`This “Prior Approval” supplemental new drug application provides for changes to section “17
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`Patient Counseling Information” of the package insert and the “How should I use Jublia?”
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`section of the patient package insert.
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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 package insert and text for
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`patient package insert), with the addition of any labeling changes in pending “Changes Being
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`Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed
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`labeling.
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`Information on submitting SPL files using eLIST may be found in the guidance for industry
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`titled “SPL Standard for Content of Labeling Technical Qs and As” at
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`Reference ID: 3709326
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` NDA 203567/S-002
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` Page 2
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
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`CM072392.pdf.
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`The SPL will be accessible via publicly available labeling repositories.
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` Also within 14 days, amend all pending supplemental applications for this NDA, including CBE
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` supplements for which FDA has not yet issued an action letter, with the content of labeling
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` [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the changes approved in this
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` 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
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` changes, as well as a clean Microsoft Word version. The marked-up copy should provide
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` 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, Regulatory Project Manager, at (301) 796
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`1015.
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`Sincerely,
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`{See appended electronic signature page}
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`Kendall A. Marcus, MD
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`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: 3709326
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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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`KENDALL A MARCUS
`02/27/2015
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`Reference ID: 3709326
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