`
`
` NDA 212690/S-005
`
`
`
`
`SUPPLEMENT APPROVAL
`
`
`
`
`
`
` Jazz Pharmaceuticals Ireland Limited
`
`
`
` Attention: Arthur Merlin d'Estreux, M.Sc.
` Director, Global Regulatory Lead – Neurosciences
`
`
` One Commerce Square
`
`
` 2005 Market Street, Suite 2100
`
` Philadelphia, PA 19103
`
`
`
`
`
`Dear Mr. d’Estreux:
`
`
`
`
`
`
`Please refer to your Supplemental New Drug Application (sNDA) dated December 22,
`
`2020, received December 22, 2020, and your amendment, submitted under section
`
`
`
`
`
`505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for XYWAV™ (calcium,
`
`
`
`
`magnesium, potassium, and sodium oxybates) oral solution 0.5 g/mL.
`
`
`
`
`
`This Prior Approval sNDA provides for a correction in Section 14 Clinical Studies of the
`
`
`
`
`
`XYWAV Prescribing Information to the number of study participants who took stimulants
`
`
`as concomitant medications in Study 1.
`
`
`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.
`
`
`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`
`
`
`
`
`Please note that we have previously granted a waiver of the requirements of 21 CFR
`
`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
`
`
`Reference ID: 4815486
`
`

`

`
`
`
`
`
` NDA 212690/S-005
` Page 2
`
`
`
` 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
`
`
`
`
`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).
`
`
`REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`
`
`(21 CFR 314.80 and 314.81).
`
`
`
`
`
`
`
`
` 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.
`
`
`
`
`
`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`
`
`Reference ID: 4815486
`
`

`

`
`
`
`
`
`
`
` NDA 212690/S-005
` Page 3
`
`
`
` If you have any questions, contact Teresa Wheelous, Regulatory Project Manager, at
`
`
` teresa.wheelous@fda.hhs.gov.
`
`
`
`
` Sincerely,
`
`
`
`{See appended electronic signature page}
`
`
`Teresa Buracchio, MD
`
`
`Deputy Director
`
`
`Division of Neurology 1
`
`Office of Neuroscience
`
`Center for Drug Evaluation and Research
`
`
`
`ENCLOSURES:
`
`
`• 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: 4815486
`
`

`

`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
`06/23/2021 09:09:01 AM
`
`Reference ID: 4815486
`
`