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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021196/S-013
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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
`Attention: Jennifer Ekelund
`Executive Director, Regulatory Affairs
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`3481 Porter Drive
`Palo Alto, CA 94304
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`Dear Ms. Ekelund:
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`We refer to your new drug application submitted under section 505(b) of the Federal Food, Drug,
`and Cosmetic Act for Xyrem (Sodium Oxybate) 500 mg/ml oral solution.
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`Please refer to your Supplemental New Drug Application (sNDA) dated August 13, 2007,
`received August 15, 2007, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Xyrem (Sodium Oxybate) 500 mg/ml oral solution.
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`We acknowledge receipt of your amendments dated February 3, 2011, April 24, 2012, and
`October 3, 2012.
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`This “Prior Approval” supplemental new drug application provides for compliance with the final
`rule, “Requirements on Content and Format of Labeling for Human Prescription Drug and
`Biological Products.”
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`We have completed our review of this supplemental application, as amended and 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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert, text for the
`patient package insert, Medication Guide), 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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`Reference ID: 3231956
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`Information on submitting SPL files using eLIST may be found in the guidance for industry
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`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 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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`All promotional materials that include representations about your drug product must be promptly
`revised to be consistent with the labeling changes approved in this supplement, including any
`new safety information [21 CFR 314.70(a)(4)]. The revisions in your promotional materials
`should include prominent disclosure of the important new safety information that appears in the
`revised package labeling. Within 7 days of receipt of this letter, submit your statement of intent
`to comply with 21 CFR 314.70(a)(4) to the address above or by fax to 301-847-8444.
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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 Susan Daugherty, Regulatory Project Manager, at
`(301) 796-0878.
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`ENCLOSURE(S):
`Content of Labeling
`Medication Guide
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`Reference ID: 3231956
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`Sincerely,
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`{See appended electronic signature page}
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`Russell Katz, MD
`Director
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`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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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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`RUSSELL G KATZ
`12/17/2012
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`Reference ID: 3231956
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