`
`Approval Package for:
`
`APPLICATION NUMBER:
`212480Orig1s000
`
`
`Trade Name:
`
`SOVALDI 150 mg and 200 mg oral pellets
`
`Generic or Proper
`Name:
`Sponsor:
`
`
`
`Sofosbuvir
`
`Gilead Sciences, Inc.
`
`Approval Date:
`
`August 28th, 2019
`
`Indication:
`
`For the treatment of chronic hepatitis C virus (HCV),
`genotypes 2 or 3 infection in pediatric patients 3 years of
`age and older without cirrhosis or with compensated
`cirrhosis in combination with ribavirin.
`
`
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`212480Orig1s000
`
`CONTENTS
`
`Reviews / Information Included in this NDA Review.
`
`Approval Letter
`Other Action Letters
`Labeling
`REMS
`Officer/Employee List
`Multidiscipline Review(s)
` Summary Review
` Office Director
` Cross Discipline Team Leader
` Clinical
` Non-Clinical
` Statistical
` Clinical Pharmacology
`Product Quality Review(s)
`Clinical Microbiology / Virology Review(s)
`Other Reviews
`Risk Assessment and Risk Mitigation Review(s)
`Proprietary Name Review(s)
`Administrative/Correspondence Document(s)
`
`X
`
`X
`
`X
`X
`
`X
`X
`X
`
`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`APPLICATION NUMBER:
`212480Orig1s000
`
`APPROVAL LETTER
`
`
`
`NDA 212480
`
`Gilead Sciences, Inc.
`Attention: Xiaoping Qi, M.S., RAC
`Associate Director, Regulatory Affairs
`333 Lakeside Drive
`Foster City, CA 94404
`
`Dear Ms. Qi:
`
`NDA APPROVAL
`
`Please refer to your new drug application (NDA) dated and received on
`February 28, 2019, and your amendments, submitted under section 505(b) of the
`Federal Food, Drug, and Cosmetic Act (FDCA) for SOVALDI (sofosbuvir) oral pellets,
`150 mg and 200 mg.
`
`This new drug application provides for the following:
`• The use of SOVALDI (sofosbuvir) 150 mg and 200 mg oral pellets for the
`treatment of chronic hepatitis C virus (HCV), genotypes 2 or 3 infection in
`pediatric patients 3 years of age and older without cirrhosis or with compensated
`cirrhosis in combination with ribavirin.
`• To make corresponding changes to the Patient Information
`
`APPROVAL & LABELING
`
`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.
`
`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of
`Highlights of Prescribing Information. This waiver applies to all future supplements
`containing revised labeling unless we notify you otherwise.
`
`CONTENT OF LABELING
`
`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
`
`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`Reference ID: 4483740
`
`
`
`NDA 212480
`Page 2
`
`
`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
`
`The SPL will be accessible via publicly available labeling repositories.
`
`CARTON AND CONTAINER LABELING
`
`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 212480.” Approval of this
`submission by FDA is not required before the labeling is used.
`
`MARKET PACKAGE
`
`Please submit one market package of the drug product when it is available to the
`following address:
`
`
`CAPT Anitra Johnson, DHSc, MSN, RN
`Food and Drug Administration
`Center for Drug Evaluation and Research
`White Oak Building 22, Room: 6362
`10903 New Hampshire Avenue
`Silver Spring, Maryland
`Use zip code 20903 if shipping via United States Postal Service (USPS).
`Use zip code 20993 if sending via any carrier other than USPS (e.g., UPS, DHL,
`FedEx).
`
`
`
`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.
`
`
`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.
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4483740
`
`
`
`NDA 212480
`Page 3
`
`
`We are waiving the pediatric study requirement from birth to 3 years of age because
`necessary studies are impossible or highly impracticable. This is due to a high rate of
`spontaneous HCV clearance resulting in very few patients requiring treatment in this
`age group.
`
`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.
`
`We note that you have fulfilled the pediatric study requirement for ages 3 to less than 12
`years for this application.
`
`PROMOTIONAL MATERIALS
`
`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:
`
`
`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`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
`
`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
`
`
`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.
`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`6 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4483740
`
`
`
`NDA 212480
`Page 4
`
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call CAPT Anitra Johnson, DHSc, MSN, RN, Regulatory
`Project Manager, at 301-796-4876.
`
`
`
`Sincerely,
`
`{See appended electronic signature
`page}
`
`Debra Birnkrant, MD
`Director
`Division of Antiviral Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and
`Research
`
`
`ENCLOSURE(S):
`• Content of Labeling
`o Prescribing Information
`o Patient Package Insert
`• Carton and Container Labeling
`
`
`
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4483740
`
`
`
`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/
`------------------------------------------------------------
`
`DEBRA B BIRNKRANT
`08/28/2019 12:55:22 PM
`
`Reference ID: 4483740
`
`