REMS File
Advair Diskus 
| Brand Name | Advair Diskus |
| Generic Name | fluticasone propionate and salmeterol xinafoate |
| Marketed by | GlaxoSmithKline PLC |
| NDA/BLA Holder | GlaxoSmithKline |
| NDA/BLA Number | NDA 21-077/S-029 |
| NDA/BLA Approval Date | 8/24/2000 |
| Status | Approved |
| Review Classification | Standard |
| REMS Approval Date | 4/30/2008 |
| Class REMS | No |
| REMS Source Document | http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021077029ltr.pdf |
| Boxed Warning? | Yes |
| Boxed Warning | Risk of Asthma Related Death |
| Indication | ADVAIR DISKUS is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: |
| Route of Administration | Oral inhalation |
| Mechanism of Action | Since 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. |
| Risks | Asthma 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 Labeling | http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021077s029lbl.pdf |
| Medication Guide? | Yes |
| Medication Guide | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm111326.pdf |
| Medication Guide Version | 2008 |
| Communication Plan? | No |
| Communication Plan | Not Applicable |
| Elements to Assure Safe Use? | No |
| Elements to Assure Safe Use | Not Applicable |
| Implementation System? | No |
| Implementation System | Not Applicable |
| Assessment Program | a. Survey of patients |
| Assessment Program Timeline | 1st 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 Program | No |
| Program Description | Not Applicable |
| Link to Branded Program | Not Applicable |
| Deemed/Approved | Approved |
| Approval Letters | http://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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