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`U.S. FOOD & DRUG
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`ADMINISTRATION
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` NDA 21976/S-65
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` NDA 202895/S-34
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` SUPPLEMENT APPROVALS
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` Janssen Products, LP
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` c/o Janssen Research & Development, LLC
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` Attention: Kara Christie
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` Associate Director, Global Regulatory Affairs
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` 920 US Highway 202
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` Raritan, NJ 08869
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`Dear Ms. Christie:
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`Please refer to your supplemental new drug applications (sNDAs) dated and received
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`September 8, 2021, and your amendments, submitted under section 505(b) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for NDA 21976, Prezista (darunavir)
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`tablets and NDA 202895, Prezista (darunavir) oral solution.
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`These Prior Approval supplemental new drugs applications provide for the following
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`changes to labeling:
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` Removal of cisapride from CONTRAINDICATIONS and DRUG INTERACTIONS
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`sections because the product is no longer marketed nor distributed in the U.S.
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` Updates USE IN SPECIFIC POPULATIONS, Pregnancy, Risk Summary and
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`Human Data sections with the latest data from the Antiretroviral Pregnancy
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`Registry (APR).
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` Updates the Patient Package Insert with a disclaimer regarding the list of
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`medicines to avoid when taking PREZISTA and to notify the healthcare provider
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`about all the medicines they take including topical creams.
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`APPROVAL & LABELING
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`We have completed our review of these applications, as amended. They are approved,
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`effective on the date of this letter, for use as recommended in the enclosed agreed-
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`upon labeling.
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`Reference ID: 4968576
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` NDA 21976/S-65
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` NDA 202895/S-34
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` 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
`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
`Prescription Drugs.3
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` 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
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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
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` https://www.fda.gov/media/128163/download.
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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: 4968576
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` NDA 21976/S-65
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` NDA 202895/S-34
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` Page 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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`PATENT LISTING REQUIREMENTS
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`Pursuant to 21 CFR 314.53(d)(2) and 314.70(f), certain changes to an approved NDA
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`submitted in a supplement require you to submit patent information for listing in the
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`Orange Book upon approval of the supplement. You must submit the patent information
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`required by 21 CFR 314.53(d)(2)(i)(A) through (C) and 314.53(d)(2)(ii)(A) and (C), as
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`applicable, to FDA on Form FDA 3542 within 30 days after the date of approval of the
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`supplement for the patent information to be timely filed (see 21 CFR
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`314.53(c)(2)(ii)). You also must ensure that any changes to your approved NDA that
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`require the submission of a request to remove patent information from the Orange Book
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`are submitted to FDA at the time of approval of the supplement pursuant to 21 CFR
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`314.53(d)(2)(ii)(B) and 314.53(f)(2)(iv).
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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 Andrew Gentles, Senior Regulatory Project Manager, at
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`240-402-5708 or the mainline at 301-796-1500.
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`Sincerely,
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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
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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: 4968576
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`NDA 21976/S-65
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`NDA 202895/S-34
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`Page 4
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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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`{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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`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: 4968576
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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
`04/14/2022 10:56:55 AM
`on behalf of Division Director
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`Reference ID: 4968576
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