Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217369
Company: BIOGEN INC

• Medication Guide

Products on NDA 217369

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZURZUVAE	ZURANOLONE	20MG	CAPSULE;ORAL	Prescription	None	Yes	No
ZURZUVAE	ZURANOLONE	25MG	CAPSULE;ORAL	Prescription	None	Yes	No
ZURZUVAE	ZURANOLONE	30MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217369

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
08/04/2023	ORIG-2	Approval	Type 1 - New Molecular Entity	PRIORITY	Federal Register Notice Label (PDF) Letter (PDF) Review	FR Notice of DEA Scheduling; Date of Approval – October 31, 2023

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
07/31/2024	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide	Label (PDF) Letter (PDF)

Labels for NDA 217369

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
07/31/2024	SUPPL-1	Labeling-Package Insert	Label (PDF)
07/31/2024	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)
07/31/2024	SUPPL-1	Labeling-Medication Guide	Label (PDF)
08/04/2023	ORIG-2	Approval	Label (PDF)