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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 21976/S-45
`NDA 202895/S-20
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Janssen Products, L.P.
`Attention: Karen Gerry
`Associate Director, Global Regulatory Affairs
`1125 Trenton-Harbourton Rd
`Titusville, NJ 08560
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`
`Dear Ms. Gerry:
`
`Please refer to your Supplemental New Drug Applications (sNDA) dated December 19, 2016,
`received December 19, 2016, and your amendments, submitted under section 505(b) of the
`Federal Food, Drug, and Cosmetic Act (FDCA) for Prezista® (darunavir) tablet, 75 mg, 150 mg,
`600 mg, and 800 mg and Prezista® (darunavir) oral suspension, 100 mg/mL.
`
`These Prior Approval supplemental new drug applications propose the following changes:
`1. To update the CONTRAINDICATIONS section with information regarding elbasvir and
`grazoprevir, a hepatitis C direct-acting antiviral drug.
`2. To update DRUG INTERACTIONS, Established and Other Potentially Significant Drug
`Interactions subsection with corticosteroid information.
`
`In addition, USE IN SPECIAL POPULATIONS, Pregnancy subsection was updated with
`information pertaining to the risk summary and human data. The Patient Information was
`updated with elbasvir and grazoprevir information.
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications, as amended. They are
`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
`upon labeling text.
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`WAIVER OF HIGHLIGHTS SECTION
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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.
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`Reference ID: 4113634
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`NDA 21976/S-45
`NDA 202895/S-20
`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 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
`Content of labeling must be identical to the enclosed labeling (text for the package insert, text for
`the 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 titled
`“SPL Standard for Content of Labeling Technical Qs and As”
`at http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/
`UCM072392.pdf.
`
`The SPL will be accessible from publicly available labeling repositories.
`
`Also within 14 days, amend all pending supplemental applications that include labeling changes
`for these NDAs, 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 MS Word format, that includes the
`changes approved in these supplemental applications, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, 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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`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 package insert(s) 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
`
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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
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`Reference ID: 4113634
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`NDA 21976/S-45
`NDA 202895/S-20
`Page 3
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`at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidance
`s/UCM443702.pdf ).
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`You must submit final promotional materials and package insert(s), 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 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found
`at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf.
`For more information about submission of promotional materials to the Office of Prescription
`Drug Promotion (OPDP),
`see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
`All promotional materials that include representations about your drug product must be promptly
`revised to be consistent with the labeling changes approved in this supplement, including any
`new safety information [21 CFR 314.70(a)(4)]. The revisions in your promotional materials
`should include prominent disclosure of the important new safety information that appears in the
`revised package labeling. Within 7 days of receipt of this letter, submit your statement of intent
`to comply with 21 CFR 314.70(a)(4) to the address above, by fax to 301-847-8444, or
`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/Guidance
`s/UCM443702.pdf ).
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`REPORTING REQUIREMENTS
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`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 Linda Onaga, MPH, Senior Regulatory Project Manager, at (301)
`796-0759.
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`Sincerely,
`
`{See appended electronic signature page}
`
` Debra Birnkrant, MD
` Director
` Division of Antiviral Products
` Office of Antimicrobial Products Center for Drug
`Evaluation and Research
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`ENCLOSURE:
`Content of Labeling
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`Reference ID: 4113634
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`
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`POONAM MISHRA
`06/19/2017
`on behalf of Debra Birnkrant, MD
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`Reference ID: 4113634
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`