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`
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`SUPPLEMENT APPROVAL
`
`
`Gilead Sciences, Inc.
`Attention: John Lombardo
`Senior Manager, Regulatory Affairs
`333 Lakeside Drive
`Foster City, CA 94404
`
`
`Dear Mr. Lombardo:
`
`Please refer to your supplemental new drug applications (sNDAs) dated and recieved
`August 3, 2021, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Epclusa (sofosbuvir and velpatasvir) tablets, 400/100 mg and
`200/50 mg.
`
`This Prior Approval supplemental new drug application updates the US Prescribing
`Information with clinical data regarding the use of Epclusa (sofosbuvir and velpatasvir)
`for the treatment of chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection in people who
`inject drugs (PWID), including those on medication-assisted treatment (MAT) for opioid
`use disorder.
`
`APPROVAL & LABELING
`
`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
`labeling.
`
`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`Please note that we have previously granted a waiver of the requirements of 21 CFR
`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
`
`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
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`Prescribing Information, Patient Package Insert, Instructions for Use,), with the addition
`of any labeling changes in pending “Changes Being Effected” (CBE) supplements, as
`
`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`Reference ID: 4974030
`
`
`
`NDA 208341/S-19
`Page 2
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`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 SPL Standard
`for Content of Labeling Technical Qs and As.2
`
`The SPL will be accessible from publicly available labeling repositories.
`
`Also within 14 days, amend all pending supplemental applications that include 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 Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), 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).
`
`CARTON AND CONTAINER LABELING
`
`We acknowledge your August 3, 2021, submission containing final printed carton and
`container labeling.
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
`new active ingredients (which includes new salts and new fixed combinations), new
`indications, new dosage forms, new dosing regimens, or new routes of administration
`are required to contain an assessment of the safety and effectiveness of the product for
`the claimed indication in pediatric patients unless this requirement is waived, deferred,
`or inapplicable.
`
`Because none of these criteria apply to your application, you are exempt from this
`requirement.
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and
`promotional labeling. For information about submitting promotional materials, see the
`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`Electronic Format-Promotional Labeling and Advertising Materials for Human
`Prescription Drugs.3
`
`
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
` 3
`
` For the most recent version of a guidance, check the FDA guidance web page at
`https://www.fda.gov/media/128163/download.
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4974030
`
`
`
`NDA 208341/S-19
`Page 3
`
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`You must submit final promotional materials and Prescribing Information, 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 FDA.gov.4 Information and
`Instructions for completing the form can be found at FDA.gov.5
`
`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 Talia Lindheimer, Regulatory Project Manager, at
`301-960-3449.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Debra Birnkrant, MD
`Director
`Division of Antivirals
`Office of Infectious Diseases
`Center for Drug Evaluation and Research
`
`ENCLOSURE(S):
`• Content of Labeling
`o Prescribing Information
`o Patient Package Insert
`
`
`
`
`
`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4974030
`
`
`
`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/
`------------------------------------------------------------
`
`POONAM MISHRA
`04/27/2022 01:08:26 PM
`on behalf of Division Director
`
`Reference ID: 4974030
`
`(
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