Plenaxis

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Brand NamePlenaxis
Generic Nameabarelix
Marketed byNot Marketed
NDA/BLA HolderSpeciality European
NDA/BLA NumberNDA 21-320
NDA/BLA Approval Date11/25/2003
StatusDiscontinued
Review ClassificationPriority
REMS Approval Date3/25/2008
Class REMSNot Available
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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