Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
Pediatric Labeling Date:
06/25/2010
Trade Name:
Serevent
Generic Name or Proper Name (*):
salmeterol
Indications Studied:
Asthma
Label Changes Summary:
Available data from controlled clinical trials suggest that Long Acting Beta Agonists (LABAs) increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g. inhaled corticosteroid) and LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components.
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
GlaxoSmithKline
Pediatric Exclusivity Granted Date:
03/09/2006
NNPS:
TRUE'
Therapeutic Category:
Antiasthmatic
-
-