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:
12/17/2014
Trade Name:
QNASL
Generic Name or Proper Name (*):
beclomethasone dipropionate
Indications Studied:
Treatment of the nasal symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis
Label Changes Summary:
*Indication extended to pediatric patients aged 4 years and older. *The efficacy and safety of QNASL Nasal Aerosol have been established in 2 clinical trials of 2 to 12 weeks duration in total of 1255 pediatric patients 4 to 11 years of age with symptoms of seasonal or perennial allergic rhinitis. *The local nasal effects in children aged 4-11 years were similar to those reported in patients 12 years of age and older in clinical trials *Dosing information for children aged 4-11 years *The safety and effectiveness of QNASL Nasal Aerosol in children younger than 4 years of age have not been established
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Teva
Therapeutic Category:
Antiallergy
-
-