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` NDA 205395/S-16
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`SUPPLEMENT APPROVAL
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` Janssen Products, LP
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` Attention: Karen Gerry
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` Associate Director
` 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
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`December 17, 2019, and your amendments, submitted under section 505(b) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for Prezcobix (darunavir and cobicistat)
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`tablets.
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`This Prior Approval supplemental new drug application provides for the following
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`changes to the Prezcobix US Prescribing Information (USPI):
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`1. INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION are updated
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`to include use in the pediatric population weighing at least 40 kg
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`2. ADVERSE REACTIONS, is updated with a separate section on clinical trial
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`experience in pediatric subjects
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`3. USE IN SPECIFIC POPULATIONS, Pediatric Use section is updated with
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`information regarding Prezcobix use from trial GS-US-216-0128 which evaluated
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`components of Prezcobix in pediatric subjects with HIV-1 infection aged 12 to
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`less than 18 years
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`4. CLINICAL PHARMACOLOGY, Pharmacokinetics, Specific Populations/Pediatric
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`section is updated with addition of relevant pharmacokinetic data following
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`coadministration of darunavir and cobicistat
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`5. CLINICAL STUDIES is updated with a new section containing trial results from
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`study GS-US-216-0128 in pediatric subjects
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`6. HOW SUPPLIED/STORAGE AND HANDLING section is updated with
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`information to keep Prezcobix and all medicines out of the reach of children
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`7. The Patient Information has been updated to reflect changes in the USPI
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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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`Reference ID: 4649898
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` NDA 205395/S-16
` 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
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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
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`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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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`We note that you have fulfilled the pediatric study requirement for ages 12 years to less
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`than 18 years and weighing at least 40 kg for this application.
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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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`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: 4649898
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` NDA 205395/S-16
` Page 3
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` FULFILLMENT OF POSTMARKETING REQUIREMENT
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` We have received your submission dated December 17, 2019, containing the final
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` report for the following postmarketing requirement listed in the January 29, 2015
` approval letter.
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`2845-3
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`Evaluate the pharmacokinetics, safety, and antiviral activity (efficacy)
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`of darunavir and cobicistat fixed-dose combination (FDC) tablets in
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`HIV-infected pediatric subjects 12 years to less than 18 years of age.
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`The safety and antiviral activity (efficacy) of darunavir and cobicistat
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`FDC tablets in pediatric subjects should be evaluated for a minimum of
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`24 weeks. A clinical trial in children 12 years to less than 18 years of
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`age may not be required if the dosing recommendation for the FDC
`tablets can be supported by pediatric trials already conducted with the
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`individual drug products and if the FDC produces similar exposures as
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`the individual components.
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`We have reviewed your submission and conclude that the above requirement was
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`fulfilled.
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`We remind you that there are postmarketing requirements listed in the January 29, 2015
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`approval letter and the May 28, 2019 postapproval postmarketing requirement letter that
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`are still open.
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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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`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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` 3 For the most recent version of a guidance, check the FDA guidance web page at
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` 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
`www.fda.gov
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`Reference ID: 4649898
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`NDA 205395/S-16
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`Page 4
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`If you have any questions, call Nina Mani, Senior Regulatory Project Manager, at
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`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 or Medication Guide
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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: 4649898
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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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`DEBRA B BIRNKRANT
`07/31/2020 08:39:35 AM
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`Reference ID: 4649898
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