Advair Diskus

Brand NameAdvair Diskus
Generic Namefluticasone propionate and salmeterol xinafoate
Marketed byGlaxoSmithKline PLC
NDA/BLA HolderGlaxoSmithKline
NDA/BLA NumberNDA 21-077/S-029
NDA/BLA Approval Date8/24/2000
StatusApproved
Review ClassificationStandard
REMS Approval Date4/30/2008
Class REMSNo
REMS Source Documenthttp://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021077029ltr.pdf
Boxed Warning?Yes
Boxed WarningRisk of Asthma Related Death
IndicationADVAIR DISKUS is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for:
Route of AdministrationOral inhalation
Mechanism of ActionSince ADVAIR DISKUS contains both fluticasone propionate and salmeterol, the mechanisms of action described below for the individual components apply to ADVAIR DISKUS. These drugs represent 2 classes of medications (a synthetic corticosteroid and a selective, long-acting beta-adrenergic receptor agonist) that have different effects on clinical and physiological indices.
RisksAsthma related complications
Risks (MedGuide Language)In patients with asthma, LABA medicines, such as salmeterol (one of the medicines in ADVAIR DISKUS), may increase the chance of death from asthma problems. In a large asthma study, more patients who used salmeterol died from asthma problems compared with patients who did not use salmeterol. It is not known whether fluticasone propionate, the other medicine in ADVAIR DISKUS, changes your chance of death from asthma problems seen with salmeterol.
Approved Labelinghttp://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021077s029lbl.pdf
Medication Guide?Yes
Medication Guidehttp://www.fda.gov/downloads/Drugs/DrugSafety/ucm111326.pdf
Medication Guide Version2008
Communication Plan?No
Communication PlanNot Applicable
Elements to Assure Safe Use?No
Elements to Assure Safe UseNot Applicable
Implementation System?No
Implementation SystemNot Applicable
Assessment Programa. Survey of patients
Assessment Program Timeline1st FDAAA assessment: October 2009 (18 months from approval) 2nd FDAAA assessment: April 2011 (3 years from approval) 3rd FDAAA assessment: April 2015 (7 years from approval)
Branded ProgramNo
Program DescriptionNot Applicable
Link to Branded ProgramNot Applicable
Deemed/ApprovedApproved
Approval Lettershttp://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21077_Advair%20Diskus_Approv.pdf

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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