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`,.,. .........
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`ADMINISTRATION
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` NDA 203567/S-010
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`SUPPLEMENT APPROVAL
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` Bausch Health Americas, Inc.
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` Attention: Carla Sanders
` Manager, Global Regulatory Affairs
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` 400 Somerset Corporate Blvd
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` Bridgewater, NJ 08807
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`
`Dear Ms. Sanders:
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`Please refer to your supplemental new drug application (sNDA) dated and received
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`June 4, 2021, and your amendments, submitted under section 505(b) of the Federal
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`Food, Drug, and Cosmetic Act (FDCA) for Jublia (efinaconazole) topical solution, 10%.
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`This Prior Approval sNDA provides for labeling changes to the Post Marketing
`Experience section of the Prescribing Information, Patient Package Insert and to the
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`Instructions For Use.
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`APPROVAL & LABELING
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`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
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`labeling.
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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
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`Prescribing Information, Patient Package Insert, and Instructions for Use), with the
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`addition of any labeling changes in pending “Changes Being Effected” (CBE)
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`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
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`Reference ID: 4957127
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` NDA 203567/S-010
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` Page 2
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` The SPL will be accessible from publicly available labeling repositories.
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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
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`(301) 796-1015.
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`Sincerely,
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`{See appended electronic signature page}
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`Tatiana Oussova, MD, MPH
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`Deputy Director for Safety
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`Division of Dermatology and Dentistry
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`Office of Immunology and Inflammation
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`Center for Drug Evaluation and Research
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`ENCLOSURES:
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`• Content of Labeling
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`o Prescribing Information
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`o Patient Package Insert
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`o Instructions for Use
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4957127
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`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`TATIANA OUSSOVA
`03/31/2022 06:58:54 PM
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`Reference ID: 4957127
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