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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 210455/S-001
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` Food and Drug Administration
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` Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Janssen Products, LP
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`Attention: Karen Gerry, BSc.
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`Associate Director, Global Regulatory Affairs
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`1125 Trenton-Harbourton Road
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`Titusville, NJ 08560
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`Dear Ms. Gerry:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received on August
`24, 2018, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for SYMTUZA™ (darunavir, cobicistat, emtricitabine, and tenofovir
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`alafenamide) tablets, 800/150/200/10 mg.
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`This Prior Approval supplemental new drug application provides for the following updates to
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`labeling:
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`In DOSAGE AND ADMINISTRATION, subsection 2.5 “Not Recommended During
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`Pregnancy”, addition of information clarifying the specific trimesters of pregnancy when
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`Symtuza is not recommended
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`In CONTRAINDICATIONS and DRUG INTERACTIONS, Table 4, addition of the
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`lipid modifying agent, lomitapide, and consolidation of information regarding HMG
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`CoA reductase inhibitors into a new section, entitled “Lipid Modifying Agents”
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`In ADVERSE REACTIONS, sub-section 6.1, Table 3, the baseline LDL cholesterol
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`value (mg/dL) in the SYMTUZA group was amended from 199 to 100 to correct a
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`typographical error
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`In DRUG INTERACTIONS, Table 4, addition of information that coadministration with
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`hepatitis C virus direct acting antivirals, glecaprevir/pibrentasvir is not recommended
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`In PATIENT INFORMATION’s “Who should not take PREZCOBIX?” section,
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`lomitapide was added to the list of medications not to be taken with SYMTUZA
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
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`text.
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`Reference ID: 4381545
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` NDA 210455/S-001
` Page 2
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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
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`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
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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
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` labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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` automated drug registration and listing system (eLIST), as described at
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` http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`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
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`Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed
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`labeling.
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`Information on submitting SPL files using eList may be found in the guidance for industry titled
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`“SPL Standard for Content of Labeling Technical Qs and As” at
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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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
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`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
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`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
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`changes, as well as a clean Microsoft Word version. The marked-up copy should provide
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`appropriate annotations, including supplement number(s) and annual report date(s).
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
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`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
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`(3) the Prescribing Information 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 (OPDP)
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`Reference ID: 4381545
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` NDA 210455/S-001
` Page 3
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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 (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf ).
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`You must submit final promotional materials and Prescribing Information, accompanied by a
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`Form FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)].
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`Form FDA 2253 is available at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
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`more information about submission of promotional materials to the Office of Prescription Drug
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`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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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 Nina Mani, Senior Regulatory Project Manager, at (301) 796
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`1500.
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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 Antiviral Products
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`Office of Antimicrobial Products
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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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`Prescribing Information
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`Patient Package Insert
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`Reference ID: 4381545
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`Signature Page 1 of 1
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`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.
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`/s/
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`POONAM MISHRA
`01/25/2019 03:53:28 PM
`on behalf of Debra Birnkrant
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`Reference ID: 4381545
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