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` NDA 021196/S-031
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`
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` APPROVAL LETTER
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`
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`Jazz Pharmaceuticals, Inc.
`
`Attention: Wheatley Spence
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`
`
`Director, Regulatory Affairs
`2005 Market Street, 21st Floor
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`
`
`Philadelphia, PA 19103
`
`
`Dear Ms. Spence:
`
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received January
`11, 2019, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and
`
`
`Cosmetic Act (FDCA) for XYREM (Sodium oxybate) Oral Solution, 500 mg/mL.
`
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`This Prior Approval supplemental new drug application provides for:
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`
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`
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`1. The introduction of a new 6 oz (2-piece) amber bottle comprised of an
`
` and an
` base cup,
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`2. Addition of a press-in bottle adaptor (PIBA), and
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`
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`3. Addition of updates to the labeling associated with the proposed changes in the container
`
`closure system.
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`
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`APPROVAL & LABELING
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`
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`We have completed our review of this supplemental application, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling
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`text.
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`CONTAINER LABELS
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`
`Submit final printed container labels that are identical to carton and immediate container labels
`submitted on January 15, 2019, as soon as they are available, but no more than 30 days after they
`
`are printed. Please submit these labels electronically according to the guidance for industry
`
`
`Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product
`Applications and Related Submissions Using the eCTD Specifications (May 2015, Revision 3).
`
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`For administrative purposes, designate this submission “Product Correspondence – Final
`
`Printed Container Labels for approved NDA 021196/S-031.” Approval of this submission by
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`FDA is not required before the labeling is used.
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`
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`We remind you that you must comply with reporting requirements for an approved NDA set
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`forth under 21 CFR 314.80 and 314.81.
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`
`
`
`
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
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`
`
`
` NDA 021196/S-031
` Page 2
`
`
`
`
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`Sincerely,
`
`
`
`
`
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` If you have any questions, call Avani Patel, Regulatory Business Process Manager, at (240) 402
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` 1845.
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`
`
`
` {See appended electronic signature page}
`
`
`
`
`
`
`
`
`
` For
`
`David Lewis,
`
` Acting Branch Chief
`
`
` Division of Post-Marketing Activities I
`
`
` Office of Lifecycle Drug Products
` Office of Pharmaceutical Quality
`
` Center for Drug Evaluation and Research
`
`
` Enclosure:
`
` Container Labeling
`
`
`
`
`
`
`
`Ramesh
`Raghavachari
`
`Digitally signed by Ramesh Raghavachari
`Date: 5/09/2019 09:29:36AM
`GUID: 502d0913000029f375128b0de8c50020
`
`
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