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`SUPPLEMENT 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
`
`
`Dear Ms. Qi:
`
`Please refer to your supplemental new drug application (sNDA) 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)
`tablets, 45/200 mg.
`
`This Prior Approval supplemental new drug application provides for the following:
`
` The use of HARVONI® (ledipasvir and sofosbuvir) tablets, 45/200 mg, for the treatment
`of pediatric patients 3 years of age and older, weighing at least 17 kg, 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.
`
`
`Reference ID: 4483735
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`
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`NDA 205834/S-29
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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), with the addition of any labeling changes in pending “Changes Being
`Effected” (CBE) supplements, 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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`
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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
`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).
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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 205834/S-29.” Approval of this submission by FDA is not required before the
`labeling is used.
`
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`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.
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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
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`www.fda.gov
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`Reference ID: 4483735
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`NDA 205834/S-29
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`Page 3
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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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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the Prescribing Information to:
`
`
`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
`
`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
`
`
`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 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
`
`
`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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`
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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: 4483735
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`NDA 205834/S-29
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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,
`
`
`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 Information
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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: 4483735
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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 12:54:49 PM
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`Reference ID: 4483735
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