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`A D M I N I STRATION
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` NDA 021976/S-063
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`SUPPLEMENT APPROVAL
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`Janssen Products, L.P
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`Attention: Karen Gerry, BSc.
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`Associate Director, Global Regulatory Affairs
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`1125 Trenton-Harbourton Road
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`PO Box 776
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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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`February 23, 2021, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for Prezista (darunavir) Tablets.
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`This “Changes Being Effected” supplemental new drug application provides for a
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`revision to the labeling to change the presentation of the active ingredient from
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`darunavir ethanolate to darunavir and to remove the equivalency statement from
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`relevant sections of the labeling
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application. It is 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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`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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
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`Content of labeling must be identical to the enclosed labeling (text for the prescribing
`information, and text for the 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 titled SPL Standard for Content of Labeling Technical Qs and As at
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guida
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`nces/UCM072392.pdf.
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` U.S. Food & Drug Administration
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` Silver Spring, MD 20993
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` www.fda.gov
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` NDA 021976/S-063
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` Page 2
` Information on submitting SPL files using eLIST may be found in the guidance for
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` industry titled SPL Standard for Content of Labeling Technical Qs and As at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida
`nces/UCM072392.pdf.
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` The SPL will be accessible via 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 MS Word format,
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`that includes the changes approved in this supplemental application, as well as annual
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`reportable changes, and annotate each change. To facilitate review of your submission,
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`provide a highlighted or marked-up copy that shows all changes, as well as a clean
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`Microsoft Word version. The marked-up copy should provide appropriate annotations,
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`including supplement number(s) and annual report date(s).
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`CARTON AND CONTAINER LABELS
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`Submit final printed carton and container labels that are identical to enclosed carton and
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`container labels and carton and container labels submitted on February 23, 2021, as
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`soon as they are available, but no more than 30 days after they are printed. Please
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`submit these labels electronically according to the guidance for industry Providing
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`Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product
`Applications and Related Submissions Using the eCTD Specifications. For
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`administrative purposes, designate this submission “Product Correspondence – Final
`Printed Carton and Container Labels for approved NDA 021976/S-063.” Approval
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`of this submission by FDA is not required before the labeling is used.
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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, new indications, new dosage forms, new dosing regimens, or
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`new routes of administration are required to contain an assessment of the safety and
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`effectiveness of the product for the claimed indication(s) in pediatric patients unless this
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`requirement is waived, deferred, 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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` U.S. Food & Drug Administration
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` Silver Spring, MD 20993
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` www.fda.gov
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`NDA 021976/S-063
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`Page 3
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`If you have any questions, call Omolara Laiyemo, Regulatory Business Process
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`Manager, at (240) 402 - 3842.
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`Sincerely,
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`{See appended electronic signature page}
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`David Lewis, Ph.D
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`Chief, Branch II
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`Division of Post-Marketing Activities I
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`Office of Lifecycle Drug Products
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`Office of Pharmaceutical Quality
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`Center for Drug Evaluation and Research
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`Enclosures:
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`Content of Labeling
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`Carton and Container Labeling
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` U.S. Food & Drug Administration
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` Silver Spring, MD 20993
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` www.fda.gov
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`David
`Lewis
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`Digitally signed by David Lewis
`Date: 8/17/2021 09:50:51AM
`GUID: 508da72000029f287fa31e664741b577
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