`
`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
`
`NDA 21-196/S-001
`
`Orphan Medical
`Attention: Dayton Reardan, Ph.D.
`Vice President, Regulatory Affairs
`13911 Ridgedale Drive, Suite 250
`Minnetonka, MN 55305
`
`Dear Dr. Reardan:
`
`Please refer to your new drug application (NDA) dated August 8, 2002, received August 9, 2002,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Xyrem (sodium
`oxybate) Oral Solution.
`
`We acknowledge receipt of your amendments dated August 13, September 4, September 30, 2002,
`April 14, September 5, and September 15, 2003.
`
`This supplemental new drug application proposes revisions to the following:
`1. Xyrem Physician Success Program
`2. Xyrem Risk Management Program
`3. Xyrem Post-Marketing Evaluation Program
`4. Xyrem Prescription Form
`5. Xyrem Patient Video Script
`
`We have completed the review of this supplemental application, and have concluded that adequate
`information has been presented to demonstrate that the drug product is safe and effective for use as
`recommended in the agreed upon revisions. Accordingly, this application is approved effective on the
`date of this letter.
`
`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:
`
`MEDWATCH, HFD-410
`FDA
`5600 Fishers Lane
`Rockville, MD 20857
`
`We remind you that you must comply with the requirements for an approved NDA set forth under
`21 CFR 314.80 and 314.81.
`
`
`
`NDA 21-196/S-001
`Page 2
`
`If you have any questions, call Mr. Paul David, R.Ph., Senior Regulatory Project Manager, at (301)
`594-5530.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Russell Katz, M.D.
`Director
`Division of Neuropharmacological Drug Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`
`
`---------------------------------------------------------------------------------------------------------------------
`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
`11/4/03 11:10:03 AM
`
`
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