`
`NDA 21196/S-019
`
`Jazz Pharmaceuticals
`Attention: Joel Selcher, PhD
`Senior Director, Regulatory Affairs
`3180 Porter Drive
`Palo Alto, CA 94304
`
`Dear Dr. Selcher:
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`Please refer to your Supplemental New Drug Application (sNDA) dated June 18, 2013, received
`June 20, 2013, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for Xyrem (sodium oxybate) oral solution.
`
`We acknowledge receipt of your amendments dated November 25, 2013, and January 27, 2014.
`
`This “Prior Approval” supplemental new drug application provides for the addition of
`information about drug reactions with ibuprofen, diclofenac, and extended-release valproate to
`the “Dosage and Administration”, “Drug Interactions”, and “Clinical Pharmacology” sections of
`the labeling.
`
`APPROVAL & LABELING
`
`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.
`
`CONTENT OF LABELING
`
`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 and 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.
`
`
`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
`
`Reference ID: 3488552
`
`
`
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
`
`The SPL will be accessible from publicly available labeling repositories.
`
`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).
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Susan Daugherty, Regulatory Project Manager, at
`
`(301) 796-0878.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Eric Bastings, MD
`Deputy Director
`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`ENCLOSURE(S):
`Content of Labeling
`
`Reference ID: 3488552
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`ERIC P BASTINGS
`04/11/2014
`
`Reference ID: 3488552
`
`