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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 208341/S-7
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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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` Gilead Sciences, Inc.
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` Attention: Jane Sur, MBS, RAC
` Senior Associate, Regulatory Affairs
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` 333 Lakeside Drive
` Foster City, CA 94404
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`Dear Ms. Sur:
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`Please refer to your Supplemental New Drug Application (sNDA) dated August 8, 2017,
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`received August 8, 2017 submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for EPCLUSA® (sofosbuvir and velpatasvir), tablets, 400 mg/100 mg.
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`This “Changes Being Effected” supplemental new drug application proposes to revise the Patient
` Information for EPCLUSA® to incorporate text regarding hepatitis B virus infection to the
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` section entitled, “Before taking EPCLUSA, tell your healthcare provider about all of your
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` medical conditions, including if you:”. This previously approved text was inadvertently not
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` included in the final approved labeling on August 1, 2017.
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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 and with the minor editorial revisions listed below.
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`1. Please remove “Gilead Sciences” from the footer pages of labeling.
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`WAIVER OF HIGHLIGHTS SECTION
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`Please note that we have previously granted a waiver of the requirements of 21 CFR
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`201.57(d)(8) regarding the length of Highlights of prescribing information.
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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
`automated drug registration and listing system (eLIST), as described
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`at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
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`Reference ID: 4146674
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` NDA 208341/S-7
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` Page 2
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` Content of labeling must be identical to the enclosed labeling (text for the package insert, text for
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`the patient package insert, Medication Guide), with the addition of any labeling changes in
`pending “Changes Being Effected” (CBE) supplements, as well as annual reportable changes not
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`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
` “SPL Standard for Content of Labeling Technical Qs and As”
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` at http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/
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`UCM072392.pdf.
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`The SPL will be accessible from publicly available labeling repositories.
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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
`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
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`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 Linda C. Onaga, MPH Senior Regulatory Project Manager, at
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`(301) 796-0759.
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`Sincerely,
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`{See appended electronic signature page}
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`Debra Birnkrant, MD
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`Director
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`Division of Antiviral Products
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`Office of Antimicrobial Products
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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: 4146674
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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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`POONAM MISHRA
`08/31/2017
`on behalf of Debra Birnkrant, MD
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`Reference ID: 4146674
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