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`DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
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`NDA 21-196/S-009
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`Jazz Pharmaceuticals
`Attention: Jennifer Ekelund, Director, Regulatory Affairs
`3180 Porter Drive
`Palo Alto, CA 94304
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`Dear Ms. Ekelund:
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`Please refer to your supplemental new drug application dated December 29, 2005, received December
`30, 2006, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Xyrem ®
`(sodium oxybate) oral solution.
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`We also refer to your new drug application for this drug product, which was reviewed and approved
`under the restricted distribution regulations contained in 21 CFR 314.500 (Subpart H) to assure safe
`use of the product.
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`This supplemental new drug application proposes to change the Xyrem Success Program® for Patients
`– Video Script. Specifically, the video script is being updated to reflect the approval of S-005 of this
`NDA, which expanded Xyrem's approved indications to include excessive daytime sleepiness. In
`addition, the text of the script has been altered to make it more clear and concise, as well as make the
`sequence of items contained in the text more logical.
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`We have completed our review of this application and have determined that the changes to the video
`script are acceptable. Accordingly, this application is approved, effective on the date of this letter, for
`use as recommended in the enclosed, agreed-upon labeling script for use with your Xyrem Success
`Program® for Patients – Video.
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`We request that you submit a copy of the completed patient video when it is available.
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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 Jacqueline H. Ware, Pharm.D., Senior Regulatory Project Manager, at
`(301) 796-2050.
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`Sincerely,
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`{See appended electronic signature page}
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`Russell Katz, M.D.
`Director
`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`Enclosure: Xyrem Success Program® For Patients – Video Script
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