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`( Jf_ rffll U.S. FOOD & DRUG
`\-.,.::i~ -
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`ADMINISTRATION
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` NDA 214187
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` NDA 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
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`Foster City, CA 94404
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`Dear Mr. Lombardo:
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`Please refer to your new drug application (NDA) dated December 15, 2020, received
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`December 15, 2020, and your amendments, submitted under section 505(b) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for Epclusa (sofosbuvir and velpatasvir)
`oral pellets, 200/50 mg and 150/37.5 mg.
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`This new drug application provides for the use of Epclusa (sofosbuvir and velpatasvir),
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`oral pellets, for the treatment of genotypes 1, 2, 3, 4, 5, or 6, chronic hepatitis C virus
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`infection in pediatric patients who are at least 3 years of age.
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`APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`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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`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of
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`Highlights of Prescribing Information. This waiver applies to all future supplements
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`containing revised labeling unless we notify you otherwise.
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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) as well as
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`annual reportable changes not included in the enclosed labeling. Information on
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`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`Reference ID: 4809414
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` NDA 214187
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`Page 2
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`submitting SPL files using eLIST may be found in the guidance for industry SPL
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`Standard for Content of Labeling Technical Qs and As.2
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`The SPL will be accessible via publicly available labeling repositories.
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`CARTON AND CONTAINER LABELING
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`Submit final printed carton and container labeling that are identical to the enclosed
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`carton and container labeling or carton and container labeling submitted on April 7,
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`2021, as soon as they are available, but no more than 30 days after they are printed.
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`Please submit these labeling electronically according to the guidance for industry
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`Providing Regulatory Submissions in Electronic Format — Certain Human
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`Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications. For administrative purposes, designate this submission “Final Printed
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`Carton and Container Labeling for approved NDA 214187 Approval of this
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`submission by FDA is not required before the labeling is used.
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`DATING PERIOD
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`Based on the stability data submitted to date, the expiry dating period for Epclusa
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`(sofosbuvir and velpatasvir), oral pellets, shall be 24 months from the date of
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`manufacture when stored below 30°C (86°F).
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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
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`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
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`We are waiving the pediatric study requirement from birth to less than 3 years because
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`necessary studies are impossible or highly impracticable. This is because spontaneous
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`HCV clearance is possible and very few patients in this age group require treatment.
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`We note that you have fulfilled the pediatric study requirement for ages 3 years to less
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`18 years for this application.
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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.
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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: 4809414
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` NDA 214187
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`Page 3
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`PROMOTIONAL MATERIALS
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`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-
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`Electronic Format—Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials,
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`and the Prescribing Information, at the time of initial dissemination or publication,
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`accompanied by a Form FDA 2253. Form FDA 2253 is available at FDA.gov.4
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`Information and 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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`• Carton and Container Labeling
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`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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`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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`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
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`www.fda.gov
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`Reference ID: 4809414
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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/
`------------------------------------------------------------
`
`POONAM MISHRA
`06/10/2021 11:39:06 AM
`For Division Director
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`I
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`Reference ID: 4809414
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`(
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