`NDA 214187/S-01
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`SUPPLEMENT APPROVAL
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` Gilead Sciences, Inc.
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` Attention: John Lombardo
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` Senior Manager, Regulatory Affairs
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` 333 Lakeside Drive
` Foster City, CA 94404
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`Dear Mr. Lombardo:
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`Please refer to your supplemental new drug application (sNDA) dated and recieved
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`August 3, 2021, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for Epclusa (sofosbuvir and velpatasvir) pellets, 200/50 mg and
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`100/37.5 mg.
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`This Prior Approval supplemental new drug application updates the US Prescribing
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`Information with clinical data regarding the use of Epclusa (sofosbuvir and velpatasvir)
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`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
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`use disorder.
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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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`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
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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
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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
`Prescribing Information, Patient Package Insert, Instructions for Use,), with the addition
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`of any labeling changes in pending “Changes Being Effected” (CBE) supplements, as
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`Reference ID: 4974025
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` NDA 214187/S-01
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` 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
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`for Content of Labeling Technical Qs and As.2
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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
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`changes for this NDA, including CBE supplements for which FDA has not yet issued an
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`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`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
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`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
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` supplement number(s) and annual report date(s).
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` CARTON AND CONTAINER LABELING
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` We acknowledge your August 3, 2021, submission containing final printed carton and
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` container labeling.
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` REQUIRED PEDIATRIC ASSESSMENTS
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` Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
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` new active ingredients (which includes new salts and new fixed combinations), new
` indications, new dosage forms, new dosing regimens, or new routes of administration
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` 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,
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` or inapplicable.
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` Because none of these criteria apply to your application, you are exempt from this
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` requirement.
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` PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
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`promotional labeling. For information about submitting promotional materials, see the
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`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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`Electronic Format-Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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` 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.
` 3 For the most recent version of a guidance, check the FDA guidance web page at
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` https://www.fda.gov/media/128163/download.
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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: 4974025
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` NDA 214187/S-01
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` 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
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` [21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
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`Instructions for completing the form can be found at FDA.gov.5
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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 Talia Lindheimer, Regulatory Project Manager, at
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`301-960-3449.
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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 Antivirals
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`Office of Infectious Diseases
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
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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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`Instructions for Use
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` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4974025
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`Signature Page 1 of 1
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`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.
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`/s/
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`POONAM MISHRA
`04/27/2022 01:13:50 PM
`on behalf of Division Director
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`Reference ID: 4974025
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`(
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