`
`{ ~ lffll U.S. FOOD & DRUG
`
`\,.,,~~ -
`
`ADMINISTRATION
`
`
`
`
` NDA 205395/S-22
`
`
`
`SUPPLEMENT APPROVAL
`
`
`
`
` Janssen Research & Development, LLC
`
`
`
` Attention: Kara Christie
` Associate Director, Global Regulatory Affairs
`
`
` 920 US Highway 202
` Raritan, NJ 08869
`
`
`
`
`
`Dear Ms. Christie:
`
`
`
`Please refer to your supplemental new drug application (sNDA) dated and received
`
`
`September 09, 2021, and your amendments, submitted under section 505(b) of the
`
`
`
`Federal Food, Drug, and Cosmetic Act (FDCA) for Prezcobix (darunavir/cobicistat)
`
`tablets.
`
`
`
`
`
`This Prior Approval sNDA provides for the following labeling updates:
`
`
`
`
`1. CONTRAINDICATIONS, information about cytochrome P450 3A (CYP3A),
`
`mediated drug-drug interactions
`
`
`2. USE IN SPECIFIC POPULATIONS, Pregnancy section:
`
`
`i. Risk Summary section:
`
`
`- Updated to include Prezcobix is not recommended during pregnancy
`
`
`
`
`because of substantially lower exposures of darunavir and cobicistat in
`
`the second and third trimesters
`
`
`- Addition of birth defects and miscarriage information from the latest
`
`
`
`
`
`Antiretroviral Pregnancy Registry (APR) report
`
`
`
`
`
`ii. Data/Human Data section updated with the latest information for darunavir
`
`
`and cobicistat from the Antiretroviral Pregnancy Registry (APR) report
`
`
`3. Patient Information:
`“Do not take PREZCOBIX with any medicine that contains:” section with
`
`
`
`
`
`i.
`
`
`a disclaimer regarding the list of medicines
`
`
`
`“Before taking PREZCOBIX, tell your healthcare provider about all
`
`
`your medical conditions, including if you:” section with addition of
`
`
`
`
`topical creams
`
`
`
`
`
`
`ii.
`
`
`APPROVAL & LABELING
`
`
`
`We have completed our review of this application, as amended. It is approved, effective
`on the date of this letter, for use as recommended in the enclosed agreed-upon
`
`labeling.
`
`
`Reference ID: 4968681
`
`
`
`
`
`
`
`
` NDA 205395/S-22
`
` Page 2
`
`
` WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`
`
`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.
`
`
`CONTENT OF LABELING
`
`
`
`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
`
`FDA.gov.1 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 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 SPL Standard for Content of Labeling Technical Qs and As.2
`
`
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`
`
`Also within 14 days, amend all pending supplemental applications that include labeling
`
`changes 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 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 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).
`
`
`PROMOTIONAL MATERIALS
`
`
`
`You may request advisory comments on proposed introductory advertising and
`
`promotional labeling. For information about submitting promotional materials, see the
`
`
`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`
`
`Electronic Format-Promotional Labeling and Advertising Materials for Human
`
`Prescription Drugs.3
`
`
`
`
`You must submit final promotional materials and Prescribing Information, accompanied
`
`
`
`by a Form FDA 2253, at the time of initial dissemination or publication
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`
`
`
`
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`
`
` 3 For the most recent version of a guidance, check the FDA guidance web page at
`
`
`
` https://www.fda.gov/media/128163/download.
`
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`
`
`Reference ID: 4968681
`
`
`
`
`
`
`
`
`
`
` NDA 205395/S-22
`
` Page 3
`
`
` [21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
`
`
`
`
`
`
`
` Instructions for completing the form can be found at FDA.gov.5
`
`
`
`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 labeling. Within 7 days of receipt of this
`
`
`
`
`letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4).
`
`PATENT LISTING REQUIREMENTS
`
`
`
`
`Pursuant to 21 CFR 314.53(d)(2) and 314.70(f), certain changes to an approved NDA
`
`submitted in a supplement require you to submit patent information for listing in the
`
`Orange Book upon approval of the supplement. You must submit the patent information
`
`required by 21 CFR 314.53(d)(2)(i)(A) through (C) and 314.53(d)(2)(ii)(A) and (C), as
`
`
`
`applicable, to FDA on Form FDA 3542 within 30 days after the date of approval of the
`
`supplement for the patent information to be timely filed (see 21 CFR
`
`
`
`
`314.53(c)(2)(ii)). You also must ensure that any changes to your approved NDA that
`
`
`require the submission of a request to remove patent information from the Orange Book
`
`
`
`
`are submitted to FDA at the time of approval of the supplement pursuant to 21 CFR
`
`
`314.53(d)(2)(ii)(B) and 314.53(f)(2)(iv).
`
`
`REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`
`
`(21 CFR 314.80 and 314.81).
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`
`
`U.S. Food and Drug Administration
`
`
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4968681
`
`
`
`NDA 205395/S-22
`
`
`Page 4
`
`
`
`If you have any questions, call Nina Mani, Senior Regulatory Project Manager, at 301-
`
`
`
`796-1500.
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`
`Debra Birnkrant, MD
`
`Director
`
`Division of Antivirals
`
`Office of Infectious Diseases
`
`Center for Drug Evaluation and Research
`
`
`
`ENCLOSURE(S):
`
`• Content of Labeling
`
`
`o Prescribing Information
`
`
`o Patient Package Insert
`
`
`
`
`
`
`
`
`
`
`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`Reference ID: 4968681
`
`
`
`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/
`------------------------------------------------------------
`
`POONAM MISHRA
`04/14/2022 11:01:42 AM
`on behalf of Division Director
`
`Reference ID: 4968681
`
`