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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 203858/S-002
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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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`“JUXTAPID has not been studied concomitantly with other LDL-lowering agents that
`can also increase hepatic fat. Therefore, the combined use of such agents is not
`recommended.”
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`Aegerion Pharmaceuticals
`Attention: Martha Carter
`Chief Regulatory Officer and Senior Vice President
`101 Main Street, Suite 1850
`Cambridge, MA 02142
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`Dear Ms. Carter:
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`Please refer to your Supplemental New Drug Application (sNDA) dated April 9, 2013, received
`April 9, 2013, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for JUXTAPID (lomitapide) Capsules.
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`This “Prior Approval” supplemental new drug application provides for revisions to the package
`insert in response to our letter dated February 12, 2013. Specifically, the following
`modifications have been made:
`Addition of the following statement to the WARNINGS AND PRECAUTIONS section,
`1.
`5.1 Risk of Hepatotoxicity subsection (Hepatic Steatosis):
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`2.
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`Revision to Table 6 (Effect of Lomitapide on the Systemic Exposure of Coadministered
`Drugs) as follows:
`-Under “No dosing adjustments required for the following:”, the dosing of
`coadministered drugs [Atorvastatin, Rosuvastatin, Fenofibrate (micronized), Ezetimibe,
`and Extended release niacin] was further defined as SINGLE DOSE.
`-Under the header “COADMINISTERED DRUG”, the drugs Ethinyl estradiol and
`Norgestimate were added.
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`We have completed our review of this supplemental application. It is approved, effective on the
`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
`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
`automated drug registration and listing system (eLIST), as described at
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`Reference ID: 3291221
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`NDA 203858/S-002
`Page 2
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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), with the
`addition of any labeling changes in pending “Changes Being Effected” (CBE) 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
`“SPL Standard for Content of Labeling Technical Qs and As at
`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
`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
`should provide appropriate annotations, including supplement number(s) and annual report
`date(s).
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(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
`Deputy Director
`Division of Metabolism and Endocrinology Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Content of Labeling
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`Reference ID: 3291221
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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
`04/10/2013
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`Reference ID: 3291221
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