;~ IQ ; . r.(,~ { ~ 11 U.S. FOOD & DRUG
`
`ADMINISTRATION
`
`\ :;:i~
`
`
`
` NDA 021196/S-042
`
`
`
`SUPPLEMENT APPROVAL
`
`
`Jazz Pharmaceuticals, Inc.
`Attention: Matthew Marianski
`Senior Associate, Global Regulatory Affairs - Neurosciences
`One Commerce Square
`2005 Market Street, Suite 2100
`Philadelphia, PA 19103
`
`
`Dear Mr. Marianski:
`
`
`Please refer to your Supplemental New Drug Application (sNDA) dated October 5,
`2022, received October 5, 2022, and your amendment, submitted under section 505(b)
`of the Federal Food, Drug, and Cosmetic Act (FDCA) for Xyrem (sodium oxybate) oral
`solution.
`
`
`This “Changes Being Effected” sNDA provides for amending the Xyrem Instructions for
`Use (IFU) to include a warning about the reversible nature of the child-resistant
`pharmacy container caps.
`
`APPROVAL & LABELING
`
`We have completed our review of this application, as amended. It is approved, effective
`on the date of this letter, for use as recommended in the enclosed agreed-upon
`
`labeling.
`
`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
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`Prescribing Information, Instructions for Use, 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 SPL Standard for Content of Labeling Technical Qs and As.2
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`Reference ID: 5153310
`
`

`

`NDA 021196/S-042
`Page 2
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`
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`The SPL will be accessible from publicly available labeling repositories.
`
`Also within 14 days, amend all pending supplemental applications that include 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 Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), 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).
`
`PATENT LISTING REQUIREMENTS
`
`
`Pursuant to 21 CFR 314.53(d)(2) and 314.70(f), certain changes to an approved NDA
`submitted in a supplement require you to submit patent information for listing in the
`Orange Book upon approval of the supplement. You must submit the patent information
`required by 21 CFR 314.53(d)(2)(i)(A) through (C) and 314.53(d)(2)(ii)(A) and (C), as
`applicable, to FDA on Form FDA 3542 within 30 days after the date of approval of the
`supplement for the patent information to be timely filed (see 21 CFR 314.53(c)(2)(ii)).
`You also must ensure that any changes to your approved NDA that require the
`submission of a request to remove patent information from the Orange Book are
`submitted to FDA at the time of approval of the supplement pursuant to 21 CFR
`314.53(d)(2)(ii)(B) and 314.53(f)(2)(iv).
`
`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, contact Jack Dan, Regulatory Project Manager, at
`Jack.Dan@fda.hhs.gov.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Teresa Buracchio, MD
`Director
`Division of Neurology 1
`Office of Neuroscience
`Center for Drug Evaluation and Research
`
`
`
`
`
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 5153310
`
`

`

`NDA 021196/S-042
`Page 3
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`
`
`
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`ENCLOSURE(S):
` Content of Labeling
`o Prescribing Information
`o Medication Guide
`o
`Instructions for Use
`
`
`
`
`
`
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 5153310
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`TERESA J BURACCHIO
`04/04/2023 04:24:35 PM
`
`Reference ID: 5153310
`
`