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`ADMINISTRATION
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` NDA 205395/S-20
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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 and received
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`Janaury 25, 2021 and your amendments, submitted under section 505(b) of the Federal
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`Food, Drug, and Cosmetic Act (FDCA) for Prezcobix (darunavir/cobicistat) tablets.
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`This Prior Approval sNDA provides for the following labeling updates:
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`1. CONTRAINDICATIONS, removal of information regarding GI motility agent,
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`cisapride since the drug is no longer marketed in the US
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`2. DRUG INTERACTIONS, Established and Other Potentially Significant Drug
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`Interactions section, Table 1:
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`a. Corticosteroids:
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`i. Removal of specific routes of administration for corticosteroids
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`ii. Addition of “corticosteroids primarily metabolized by CYP3A”
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`iii. Edits to the dexamethasone (systemic) text and placement
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`b. Removal of cisapride information
`3. The Patient Information ““Do not take PREZCOBIX with any medicine that
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`contains:” section is updated with removal of cisapride information.
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`APPROVAL & LABELING
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`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
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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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`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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`Reference ID: 4830581
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` NDA 205395/S-20
` Page 2
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` 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
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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
`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
`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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`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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` 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
` 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
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4830581
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` NDA 205395/S-20
` Page 3
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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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` 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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`Because none of these criteria apply to your application, you are exempt from this
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`requirement.
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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 Nina Mani, Senior Regulatory Project Manager, at 301-
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`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: 4830581
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`Signature Page 1 of 1
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`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
`07/23/2021 11:38:01 AM
`on behalf of Division Director
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`Reference ID: 4830581
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