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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-012
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`Jazz Pharmaceuticals, Inc.
`ATTENTION: Jennifer Ekelund
` Senior 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 August 17, 2006, received August 18,
`2006, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Xyrem (sodium
`oxybate) oral solution 500 mg/mL.
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`We acknowledge receipt of your submissions dated September 6, 2006, September 22, 2006 and
`October 17, 2006.
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`This supplemental new drug application provides for the Patient Enrollment Form, Prescription Form
`and Physician Registration Form.
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`We have completed our review of this application, as amended. This application is approved, effective
`on the date of this letter, for use as recommended in the agreed-upon labeling text.
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`The final printed labeling (FPL) must be identical to the submitted labeling (Patient Enrollment Form,
`Prescription Form, and Physician Registration Form submitted September 22, 2006).
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`Please submit an electronic version of the FPL according to the guidance for industry titled Providing
`Regulatory Submissions in Electronic Format - NDA. Alternatively, you may submit 20 paper copies
`of the FPL as soon as it is available but no more than 30 days after it is printed. Individually mount 15
`of the copies on heavy-weight paper or similar material. For administrative purposes, designate this
`submissions "FPL for approved supplement NDA 21-196/S-012.” Approval of this submission by
`FDA is not required before the labeling is used.
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`If you issue a letter communicating important information about this drug product (i.e., a “Dear Health
`Care Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to
`the following address:
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`MEDWATCH
`Food and Drug Administration
`5515 Security Lane
`HFD-001, Suite 5100
`Rockville, MD 20852
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`NDA 21-196/S-012
`Page 2
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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, please call Jacqueline Ware, PharmD, Senior Regulatory Project Manager,
`at (301) 796-2250.
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`Sincerely,
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`{See appended electronic signature page}
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`Russell Katz, MD
`Director
`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/
`---------------------
`Russell Katz
`11/13/2006 03:29:53 PM
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