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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 203858/S-012
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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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` Aegerion Pharmaceuticals, Inc.
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` Attention: Martha J. Carter
` Chief Regulatory Officer and Senior Vice President
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` One Main Street, Suite 800
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` Cambridge, MA 02142
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`Dear Ms. Carter:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received
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`June 18, 2015, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
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`(FDCA) for Juxtapid (lomitapide) capsules.
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`This “Prior Approval” supplemental new drug application provides for revisions to the package
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`insert with respect to the use of Juxtapid in association with weak CYP3A4 inhibitors, including
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`a revision to the maximum recommended dose of Juxtapid when administered concomitantly
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`with oral contraceptives.
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`Specifically, the following sections of the labeling have been modified:
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`DOSAGE AND ADMINISTRATION, 2.1 Initiation and Maintenance of Therapy, and
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`2.3 Dosing with Cytochrome P450 3A4 Inhibitors
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`5.
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`WARNINGS AND PRECAUTIONS, 5.3 Embryo-Fetal Toxicity, and 5.6 Concomitant
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`Use of CYP3A4 Inhibitors
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`DRUG INTERACTIONS, 7.2 Weak CYP3A4 Inhibitors
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`12.
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`CLINICAL PHARMACOLOGY, Drug Interactions
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`APPROVAL & LABELING
`We have completed our review of this supplemental application. It is approved, effective on the
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`date of this letter, for use as recommended in the enclosed, agreed-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), with the
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`Reference ID: 3898657
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` NDA 203858/S-012
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` Page 2
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` addition of any labeling changes in pending “Changes Being Effected” (CBE) supplements, as
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`well as annual 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 titled
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`“SPL Standard for Content of Labeling Technical Qs and As at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
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` 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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`PROMOTIONAL MATERIALS
`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
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`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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`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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`Reference ID: 3898657
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` NDA 203858/S-012
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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 Kati Johnson, Senior Regulatory Project Manager, at (301) 796
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`Sincerely,
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`{See appended electronic signature page}
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`James P. Smith, MD, MS
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`Deputy Director
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`Division of Metabolism and Endocrinology Products
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`Office of Drug Evaluation II
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`Center for Drug Evaluation and Research
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`ENCLOSURE: Content of Labeling
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`Reference ID: 3898657
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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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`JAMES P SMITH
`03/08/2016
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`Reference ID: 3898657
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`(
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