Details for New Drug Application (NDA): 214755

NDA 214755 describes LUMRYZ, which is a drug marketed by Avadel Cns and is included in one NDA. It is available from one supplier. There are nineteen patents protecting this drug. Additional details are available on the LUMRYZ profile page.

The generic ingredient in LUMRYZ is sodium oxybate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sodium oxybate profile page.

Summary for 214755

Tradename:	LUMRYZ
Applicant:	Avadel Cns
Ingredient:	sodium oxybate
Patents:	19

Pharmacology for NDA: 214755

Physiological Effect

Central Nervous System Depression Decreased Central Nervous System Organized Electrical Activity

Medical Subject Heading (MeSH) Categories for 214755

Adjuvants, Anesthesia

Anesthetics, Intravenous

Suppliers and Packaging for NDA: 214755

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755	NDA	Avadel CNS Pharmaceuticals, LLC	13551-001	13551-001-07	7 PACKET in 1 CARTON (13551-001-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755	NDA	Avadel CNS Pharmaceuticals, LLC	13551-001	13551-001-30	30 PACKET in 1 CARTON (13551-001-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION, EXTENDED RELEASE;ORAL			Strength	4.5GM/PACKET
Approval Date:	May 1, 2023	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	May 1, 2026
Regulatory Exclusivity Use:	NEW PRODUCT
Regulatory Exclusivity Expiration:	May 1, 2030
Regulatory Exclusivity Use:	TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULTS WITH NARCOLEPSY
Patent:		Patent Expiration:	Jul 21, 2037	Product Flag?	Y	Substance Flag?		Delist Request?

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