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` NDA 212480/S-3
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`SUPPLEMENT APPROVAL
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`
` Gilead Sciences, Inc.
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`
` Attention: Solmaz Dehghan, PharmD, PhD
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` Manager, Regulatory Affairs, CMC
`
` 333 Lakeside Dr
` Foster City, CA 94404
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`
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`
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`Dear Dr. Dehghan:
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`Please refer to your supplemental new drug application (sNDA) dated and received
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`October 1, 2019, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for SOVALVDI (sofosbuvir), oral pellets.
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`This Changes Being Effected supplemental new drug application proposes to update
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`the NDC numbers on the container labels.
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`APPROVAL & LABELING
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`We have completed our review of this application. It is approved, effective on the date of
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`this letter, for use as recommended in the enclosed agreed-upon labeling.
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`CONTAINER LABELING
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`Submit final printed container labeling that are identical to the enclosed container
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`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
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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
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`Specifications. For administrative purposes, designate this submission “Final Printed
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`Container Labeling for approved NDA 212480/S-3” Approval of this submission by
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`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
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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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`Reference ID: 4528547
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` NDA 212480/S-3
` Page 2
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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. 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
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` annotated references, and (3) the Prescribing Information to:
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`
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`OPDP Regulatory Project Manager
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`Food and Drug Administration
`
`
`Center for Drug Evaluation and Research
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`Office of Prescription Drug Promotion (OPDP)
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`5901-B Ammendale Road
`
`Beltsville, MD 20705-1266
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`Alternatively, you may submit a request for advisory comments electronically in eCTD
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`
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`format. For more information about submitting promotional materials in eCTD format,
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`see the draft guidance for industry Providing Regulatory Submissions in Electronic and
`Non-Electronic Format-Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.1
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`You must submit final promotional materials and Prescribing Information, accompanied
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`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.2 Information and
`Instructions for completing the form can be found at FDA.gov.3 For more information
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`about submission of promotional materials to the Office of Prescription Drug Promotion
`(OPDP), see FDA.gov.4
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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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` 1 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
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` https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`2 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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` 3 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
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` 4 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.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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`
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`Reference ID: 4528547
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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
`
`Division of Antivirals
`
`
`Office of Infectious Diseases
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`Center for Drug Evaluation and Research
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`NDA 212480/S-3
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`Page 3
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`If you have any questions, call Linda C. Akunne, Senior Regulatory Project Manager, at
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`301-796-0759.
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`ENCLOSURES:
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`• Container Labeling
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`
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`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
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`www.fda.gov
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`
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`Reference ID: 4528547
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`
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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
`12/04/2019 10:03:33 AM
`on behalf of Debra Birnkrant
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`Reference ID: 4528547
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`