`NDA 205395/S-018
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`SUPPLEMENT APPROVAL
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` Janssen Products, LP
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` Attention: Karen Gerry, BSc
` 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 May 28, 2020,
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` received May 28, 2020, and your amendments, submitted under section 505(b) of the
` Federal Food, Drug, and Cosmetic Act (FDCA) for Prezcobix (darunavir and cobicistat)
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` tablet.
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` This Prior Approval supplemental new drug application provides for the following
` changes to the Prezcobix US Prescribing Information (USPI):
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` • WARNINGS AND PRECAUTIONS, Risk of Serious Adverse Reactions or Loss
` of Virologic Response Due to Drug Interactions section, is updated with
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` information for drugs that have active metabolite(s) formed by CYP3A and
` possible loss of their therapeutic effect.
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` • DRUG INTERACTIONS:
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` o Potential for PREZCOBIX to Affect Other Drugs section with information
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` regarding the effect of co-administration with medications metabolized by
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` CYP3A.
` o Table 1 is updated with the addition of information about platelet
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` aggregation inhibitors clopidogrel and prasugrel
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` APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`on the date of this letter, for use as recommended in the enclosed agreed-upon
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`labeling.
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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: 4721396
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` NDA 205395/S-018
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` 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
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
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` FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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` Prescribing Information and Patient Package Insert), with the addition of any labeling
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` changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
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` reportable changes not included in the enclosed labeling.
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` 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
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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
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`changes for this NDA, including CBE supplements for which FDA has not yet issued an
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`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`format, that includes the changes approved in this supplemental application, as well as
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`annual reportable changes. To facilitate review of your submission(s), provide a
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`highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
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`Word version. The marked-up copy should provide appropriate annotations, including
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`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
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`promotional labeling. For information about submitting promotional materials, see the
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`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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`Electronic Format-Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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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.4 Information and
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`Instructions for completing the form can be found at FDA.gov.5
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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` 3 For the most recent version of a guidance, check the FDA guidance web page at
` https://www.fda.gov/media/128163/download.
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` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`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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`Reference ID: 4721396
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` NDA 205395/S-018
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` Page 3
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` All promotional materials that include representations about your drug product must be
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` promptly revised to be consistent with the labeling changes approved in this
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` supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
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` in your promotional materials should include prominent disclosure of the important new
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` safety information that appears in the revised labeling. Within 7 days of receipt of this
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` letter, submit your statement of intent to comply with 21 CFR 314.70(a)(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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` If you have any questions, call London Harrison, MBEE, Regulatory Project Manager, at
` 301-348-3926 or the mainline at 301-796-1500.
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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 Antivirals
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` Office of Infectious Diseases
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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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` o Prescribing Information
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` o Patient Package Insert
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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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`Reference ID: 4721396
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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
`12/22/2020 02:53:11 PM
`on behalf of Division Director
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`Reference ID: 4721396
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