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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 210455/S-005
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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
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`February 7, 2019, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for SYMTUZA™ (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide)
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`tablets, 800mg/150mg/200mg/10 mg.
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`This “Changes Being Effected” supplemental new drug application provides an update to the
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`“HIGHLIGHTS OF PRESCRIBING INFORMATION; RECENT MAJOR CHANGES” section
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`of the labeling by adding “Contraindications”. This change was inadvertently omitted from the
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`labeling of the supplemental application approved on January 25, 2019 in which lomitapide was
`added to Section 4 CONTRAINDICATIONS.
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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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`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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`Reference ID: 4393793
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` NDA 210455/S-005
` 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
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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
`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
`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,
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`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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`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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`Reference ID: 4393793
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` NDA 210455/S-005
` Page 3
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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: 4393793
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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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`POONAM MISHRA
`02/25/2019 04:41:16 PM
`on behalf of Debra Birnkrant
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`Reference ID: 4393793
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`(
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