Enbrel for Subcutaneous Injection

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Brand NameEnbrel for Subcutaneous Injection
Generic Nameetanercept
Marketed byImmunex Corp. Amgen Inc.
NDA/BLA HolderImmunex / Amgen
NDA/BLA NumberBLA 103795/5359
NDA/BLA Approval Date11/2/1998
StatusApproved
Review ClassificationNot Applicable
REMS Approval Date6/23/2008
Class REMSTNF-Blocker
REMS Source Document
Boxed Warning?
Boxed Warning
Indication
Route of Administration
Mechanism of Action
Risks
Risks (MedGuide Language)
Approved Labeling
Medication Guide?
Medication Guide
Medication Guide Version
Communication Plan?
Communication Plan
Elements to Assure Safe Use?
Elements to Assure Safe Use
Implementation System?
Implementation System
Assessment Program
Assessment Program Timeline
Branded Program
Program Description
Link to Branded Program
Deemed/Approved
Approval Letters

Sources

REMS Document: from FDA Approved REMS
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

Approval Letters: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

Approved Labeling: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

Medication Guide: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

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