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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21976/S-34
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` NDA 202895/S-11
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`Food and Drug Administration
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` Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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` Janssen Therapeutics, a Division of Janssen Products, LP
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` Attention: Karen Gerry, BSc
` Manager, 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 October 18, 2013,
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`received October 18, 2013, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Prezista® (darunavir) tablets, 75 mg, 150 mg, 600 mg, and 800 mg,
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`and Prezista® (darunavir) oral suspension, 100 mg/mL.
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`We acknowledge receipt of your amendments dated February 28, 2014 and March 18, 2014.
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`These Prior Approval supplemental new drug applications propose the following revisions to the
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`labeling:
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`• To add information regarding rash with eosinophilia and systemic symptoms
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`• To add drug interaction information for dolutegravir and in vitro antiviral activity data for
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`rilpivirine
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`• To remove information related to the 400 mg tablet strength of darunavir and ergonovine
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`because they are no longer marketed and distributed in the United States.
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications, as amended. They are
`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
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`upon labeling text.
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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 content of
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling (text for the package insert, text for the
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`Reference ID: 3485781
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` NDA 21976/S-34
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` NDA 202895/S-11
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` Page 2
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`patient package insert, Medication Guide), with the addition of any labeling changes in pending
`“Changes Being Effected” (CBE) supplements, as well as annual reportable changes not
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`included in the enclosed labeling.
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` Information on submitting SPL files using eList may be found in the guidance for industry titled
` “SPL Standard for Content of Labeling Technical Qs and As at
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
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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 includes labeling changes
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`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
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`changes approved in this supplemental application, as well as annual reportable changes and
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`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
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`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
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`should provide appropriate annotations, including supplement number(s) and annual report
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`date(s).
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`WAIVER OF HIGHLIGHTS SECTION
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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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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
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`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
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`administration are required to contain an assessment of the safety and effectiveness of the
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`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
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`deferred, or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this requirement.
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`PROMOTIONAL MATERIALS
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`All promotional materials that include representations about your drug product must be promptly
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`revised to be consistent with the labeling changes approved in this supplement, including any
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`new safety information [21 CFR 314.70(a)(4)]. The revisions in your promotional materials
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`should include prominent disclosure of the important new safety information that appears in the
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`revised package labeling. Within 7 days of receipt of this letter, submit your statement of intent
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`to comply with 21 CFR 314.70(a)(4) to the address above or by fax to 301-847-8444.
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`Reference ID: 3485781
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`Sincerely,
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`{See appended electronic signature page}
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`Kendall Marcus, MD
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`Deputy Director of Safety
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`Division of Antiviral Products
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`Office of Antimicrobial Products
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`Center for Drug Evaluation and Research
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` NDA 21976/S-34
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` NDA 202895/S-11
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` Page 3
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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 Linda C. Onaga, MPH, Regulatory Project Manager, at (301)
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`796-0759 or the Division mainline at (301) 796-1500.
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`ENCLOSURE(S):
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`Content of Labeling
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`Reference ID: 3485781
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`KENDALL A MARCUS
`04/07/2014
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`Reference ID: 3485781
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