NDA 212477
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`NDA APPROVAL
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` Gilead Sciences, Inc.
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`Attention: Xiaoping Qi, MS, RAC
`Associate Director, Regulatory Affairs
`
`333 Lakeside Drive
`Foster City, CA 94404
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`Dear Ms. Qi:
`
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`Please refer to your new drug application (NDA) dated February 28, 2019, received February 28,
`2019, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for HARVONI® (ledipasvir and sofosbuvir) oral pellets, 33.75 mg/150
`mg and 45 mg/200 mg.
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`This new drug application provides for the following:
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` The use of HARVONI® (ledipasvir and sofosbuvir) oral pellets, 33.75 mg/150 mg,
`45 mg/200 mg, for the treatment of pediatric patients 3 years of age and older with
`chronic hepatitis C virus (HCV):
`o genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
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`o genotype 1 infection with decompensated cirrhosis, for use in combination with
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`ribavirin
`o genotype 1 or 4 liver transplant recipients without cirrhosis or with compensated
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`cirrhosis, for use in combination with ribavirin
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` To make corresponding changes to the Patient Information
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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 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
`201.57(d)(8) regarding the length of Highlights of prescribing information.
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`
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`Reference ID: 4483725
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`NDA 212477
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`Page 2
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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
`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 and
`Patient Package Insert) as 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
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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 carton and
`container labeling, as soon as they are available, but no more than 30 days after they are printed.
`Please submit these labeling electronically according to the guidance for industry Providing
`Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product
`Applications and Related Submissions Using the eCTD Specifications. For administrative
`purposes, designate this submission “Final Printed Carton and Container Labeling for
`approved NDA 212477.” Approval of this submission by FDA is not required before the
`labeling is used.
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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 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.
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`We are waiving the pediatric study requirement for age 0 to 3 years because studies are
`impossible or highly impracticable due to spontaneous HCV clearance resulting in very few
`patients requiring treatment in this age group.
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`This product is appropriately labeled for the use in ages 12 to 17 years of age for this indication.
`Therefore, no additional studies are needed in this pediatric group.
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`We note that you have fulfilled the pediatric study requirement for ages 3 to less than 12 years
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`for this application.
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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
`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
`www.fda.gov
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`Reference ID: 4483725
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`NDA 212477
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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. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and the Prescribing
`Information, Medication Guide, and Patient Package Insert (as applicable) to:
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`OPDP Regulatory Project Manager
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`Office of Prescription Drug Promotion
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`
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`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
`For more information about submitting promotional materials in eCTD format, see the draft
`guidance for industry Providing Regulatory Submissions in Electronic and Non-Electronic
`Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs.3
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`Prescribing Information, at the time of initial dissemination or publication, accompanied by a
`Form FDA 2253. Form FDA 2253 is available at FDA.gov.4 Information and Instructions for
`completing the form can be found at FDA.gov.5 For more information about submission of
`promotional materials to the Office of Prescription Drug Promotion (OPDP), see FDA.gov.6
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`3 When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent
`version of a guidance, check the FDA guidance web page at
`https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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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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` 6 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm
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`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4483725
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`

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`NDA 212477
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`Page 4
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`If you have any questions, contact Philip Villasurda, Regulatory Project Manager, at
`Philip.Villasurda@fda.hhs.gov or call at (301) 796-2586 or (301) 796-1500.
`
`
`Sincerely,
`
` {See appended electronic signature page}
`
`
`
`Debra
` Birnkrant,
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`Director
`Division of Antiviral Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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` MD
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`ENCLOSURE(S):
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` Content of Labeling
`o Prescribing Information
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`o Patient Package Insert
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` Carton and Container Labeling
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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: 4483725
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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/
`------------------------------------------------------------
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`DEBRA B BIRNKRANT
`08/28/2019 12:53:57 PM
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`Reference ID: 4483725
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