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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021196/S-027
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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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` Jazz Pharmaceuticals
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` Attention: Kristine Chang
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` Associate Director, US Regulatory Affairs
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` 3180 Porter Drive
` Palo Alto, CA 94304
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`Dear Ms. Chang:
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`Please refer to your Supplemental New Drug Application (sNDA) dated July 26, 2016, received
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`July 26, 2016, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
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`(FDCA) for Xyrem® (sodium oxybate).
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`This “Changes Being Effected” supplemental new drug application proposed the following
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`change(s):
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`The proposed changes involve 4 sections of the Prescribing Information.
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`• Highlights of Prescribing Information (addition of word “Inc.”)
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`• Section 5.6 (addition of a single adverse reaction term, aggression, to the existing
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`Warnings and Precautions subsection “Other Behavioral or Psychiatric Adverse
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`Reactions”)
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`• Section 6.2 (addition of a single adverse reaction term, nocturia)
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`• Section 11 (change to graphic showing chemical structure of sodium oxybate).
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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.
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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, Medication
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`Reference ID: 4046630
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` NDA 021196/S-027
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` Page 2
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` Guide, and Instructions for Use), with the addition of any labeling changes in pending “Changes
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` Being Effected” (CBE) supplements, as well as annual reportable changes not included in the
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` 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 include 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
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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
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`(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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`Reference ID: 4046630
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` NDA 021196/S-027
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` Page 3
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` You must submit final promotional materials and package insert(s), accompanied by a Form
` 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
`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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`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, contact Vandna Kishore, Regulatory Project Manager, at
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`Vandna.Kishore@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Alice Hughes, M.D.
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`Deputy Director for Safety
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`Division of Neurology
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`Office of Drug Evaluation I
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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: 4046630
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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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`ALICE HUGHES
`01/26/2017
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`Reference ID: 4046630
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