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` NDA 21196/S-032
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` Jazz Pharmaceuticals, Inc.
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` Attention: Arthur Merlin d'Estreux
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` Director, Regulatory Affairs
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` 2005 Market Street
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` Philadelpia, PA 19103
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` SUPPLEMENT APPROVAL
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` Dear Mr. d'Estreux:
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` Please refer to your Supplemental New Drug Application (sNDA) dated November 26,
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` 2019, received November 26, 2019, and your amendments, submitted under Section
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` 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Xyrem® (sodium
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` oxybate) oral solution 0.5 g/mL.
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` This Prior Approval Supplemental New Drug Application proposes changes to the
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` labeling for Xyrem based on the final clinical study report for the Phase 3 pediatric
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` clinical trial 13-005. The proposed revisions include changes to the Prescribing
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` Information [Highlights; Warnings and Precautions (Section 5); Adverse Reactions
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` (Section 6); and Use in Specific Populations (Section 8)] and to the Medication Guide.
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` APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`on the date of this letter, for use as recommended in the enclosed agreed-upon
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`labeling.
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`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
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`Please note that we have previously granted a waiver of the requirements of 21 CFR
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`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
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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
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`Prescribing Information, Instructions for Use, and Medication Guide), with the addition of
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`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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` Reference ID: 4676451
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` NDA 21196/S-032
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` Page 2
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`any labeling changes in pending “Changes Being Effected” (CBE) supplements, as well
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`as annual reportable changes not included in the enclosed labeling.
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`Information on submitting SPL files using eList may be found in the guidance for
`industry SPL Standard for Content of Labeling Technical Qs and As.2
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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 that include labeling
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`changes for this NDA, including CBE supplements for which FDA has not yet issued an
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`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`format, that includes the changes approved in this supplemental application, as well as
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`annual reportable changes. To facilitate review of your submission(s), provide a
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`highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
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`Word version. The marked-up copy should provide appropriate annotations, including
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`supplement number(s) and annual report date(s).
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, contact Teresa Wheelous, Regulatory Project Manager, at
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`teresa.wheelous@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Eric Bastings, MD
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`Director (Acting)
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`Division of Neurology 1
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`Office of Neuroscience
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`Center for Drug Evaluation and Research
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`ENCLOSURES:
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`Content of Labeling
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`o Prescribing Information
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`o Medication Guide
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`Instructions for Use
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` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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` Reference ID: 4676451
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` Signature Page 1 of 1
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`This is a representation of an electronic record that was signed
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`electronically. Following this are manifestations of any and all
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`electronic signatures for this electronic record.
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`/s/
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`ERIC P BASTINGS
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`09/25/2020 04:53:47 PM
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`Reference ID: 4676451
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