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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214755
Company: AVADEL CNS

Medication Guide

REMS

Products on NDA 214755

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUMRYZ	SODIUM OXYBATE	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes
LUMRYZ	SODIUM OXYBATE	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
LUMRYZ	SODIUM OXYBATE	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
LUMRYZ	SODIUM OXYBATE	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214755

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2023	ORIG-1	Approval		STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214755Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214755Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/214755Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2024	SUPPL-11	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214755Orig1s011ltr.pdf
09/26/2024	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214755s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214755Orig1s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/214755Orig1s007.pdf
10/16/2024	SUPPL-6	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214755s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214755Orig1s006ltr.pdf
10/31/2023	SUPPL-3	REMS - MODIFIED - D-N-A	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214755Orig1s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/214755Orig1s003.pdf

Labels for NDA 214755

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/16/2024	SUPPL-6	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214755s006lbl.pdf
09/26/2024	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214755s007lbl.pdf
05/01/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214755Orig1s000lbl.pdf

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