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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 21976/S-43
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` NDA 202895/S-17
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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 Products, LP
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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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`Titusville, NJ 08560
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`Dear Ms. Gerry:
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`Please refer to your Supplemental New Drug Applications (sNDAs) dated and received
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`December 17, 2015 and your amendments, submitted under section 505(b) of the Federal Food,
`Drug, and Cosmetic Act (FDCA) for PREZISTA® (darunavir) tablet, 75 mg, 150 mg, 600 mg,
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`800 mg (NDA 21976), and PREZISTA® (darunavir) oral suspension, 100 mg/mL (NDA
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`202895).
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`These Prior Approval supplemental new drug applications propose the following changes:
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`1. To update the DOSAGE AND ADMINISTRATION and CLINICAL
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`PHARMACOLOGY, Pharmacokinetics sections of the labeling with data and results
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`from a study investigating the use of darunavir during pregnancy and postpartum
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`2. To update USE IN SPECIFIC POPULATIONS sections 8.1 through 8.3 to be compliant
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`with the “Pregnancy and Lactation Labeling Rule”
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`In addition, the Agency proposed the following changes:
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`3. To remove WARNINGS AND PRECAUTIONS, Resistance/Cross-Resistance subsection
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`4. To update DRUG INTERACTIONS section:
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`a. Add clinical comments regarding the co-administration of omeprazole to Table
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`11.
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`b. Create new section (section 7.4) to include drugs without clinically significant
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`interaction with Prezista.
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`c. Remove H2 blockers and antacids because of the absence of supporting
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`information to provide clinical recommendation regarding co-administration with
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`Prezista.
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`d. Remove telaprevir information from DRUG INTERACTIONS, Table 11 and
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`CLINICAL PHARMACOLOGY, Table 17 because telaprevir is no longer
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`marketed nor distributed in the United States.
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`5. To update CLINICAL PHARMACOLOGY section with addition of Figure 1 to display
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`darunavir exposure changes in pregnant subjects by trimester.
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`Reference ID: 3947678
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`

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`NDA 21976/S-43
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`NDA 202895/S-17
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`Page 2
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` 6. To reformat and revise the PATIENT COUNSELING INFORMATION based upon the
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` Agency’s current standard.
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` 7. To reformat and revise the PATIENT INFORMATION based upon the Agency’s current
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` standard.
` 8. To update the INSTRUCTIONS FOR USE.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
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`text and with the minor editorial revisions listed below.
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`• Under RECENT MAJOR CHANGES we changed
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`WARNINGS AND PRECAUTIONS, (5.10)
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`to
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`WARNINGS AND PRECAUTIONS, Resistance/Cross-Resistance (5.10) Removed
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`06/2016
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`Removed (06/2016)
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`WAIVER OF HIGHLIGHTS SECTION
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`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of
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`prescribing information. This waiver applies to all future supplements containing revised
`labeling unless we notify you otherwise.
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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
`of labeling must be identical to the enclosed labeling (text for the package insert and text for the
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`patient package insert), with the addition of any labeling changes in pending “Changes Being
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`Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed
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`labeling.
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`Information on submitting SPL files using eList may be found in the guidance for industry titled
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`“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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`Reference ID: 3947678
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`NDA 21976/S-43
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`NDA 202895/S-17
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`Page 3
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` Also within 14 days, amend all pending supplemental applications that includes labeling changes
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` for these NDAs, 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
`date(s).
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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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`You may request advisory comments on proposed introductory advertising and promotional
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`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
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`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
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`OPDP Regulatory Project Manager
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`Office of Prescription Drug Promotion (OPDP)
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
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`For more information about submitting promotional materials in eCTD format, see the draft
`Guidance for Industry (available at:
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`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf ).
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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`FDA 2253 is available at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
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`Reference ID: 3947678
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`

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`NDA 21976/S-43
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`NDA 202895/S-17
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`Page 4
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` more information about submission of promotional materials to the Office of Prescription Drug
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` Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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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, Regulatory Project Manager, at (240) 402-0333.
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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 Antiviral Products
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`Office of Antimicrobial Products
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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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`Reference ID: 3947678
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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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`DEBRA B BIRNKRANT
`06/17/2016
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`Reference ID: 3947678
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