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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 203858/S-006
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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
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` Chief Regulatory Officer and Senior Vice President
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` 101 Main Street, Suite 1850
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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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`December 12, 2013, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
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`Act (FDCA) for Juxtapid (lomitapide) Capsules, 5, 10, and 20 mg.
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`This “Prior Approval” supplemental new drug application provides for the following revisions to
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`the package insert:
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`-Section 8.1 (Pregnancy) has been modified to incorporate information about the Global
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`Lomitapide Pregnancy Exposure Registry (PER) and to provide an additional method (phone)
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`for obtaining information about the registry.
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`-Section 17 (Patient Counseling Information) has been modified to provide an additional method
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`(phone) for obtaining more information about the registry.
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`Similar revisions are proposed for the MedGuide.
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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 and Medication
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`Guide), with the addition of any labeling changes in pending “Changes Being Effected” (CBE)
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`supplements, as 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
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`Reference ID: 3455766
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` NDA 203858/S-006
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` Page 2
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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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`REPORTING REQUIREMENTS
`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, Regulatory Project Manager, at (301) 796-1234.
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`Sincerely,
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`{See appended electronic signature page}
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`Eric Colman, MD
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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:
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`Content of Labeling (Package Insert, MedGuide)
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`Reference ID: 3455766
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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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`ERIC C COLMAN
`02/18/2014
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`Reference ID: 3455766
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