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:
10/15/2009
Trade Name:
Crestor
Generic Name or Proper Name (*):
rosuvastatin
Indications Studied:
Heterozygous familial hypercholesterolemia
Label Changes Summary:
New indication in adolescent boys and girls (at least one year post-menarche) 10-17 years with heterozygous familial hypercholesterolemia Has not been studied in children < 10 years or in pre-menarchal girls Information on dose, adverse events and clinical studies
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
AstraZeneca
Pediatric Exclusivity Granted Date:
07/07/2009
NNPS:
FALSE'
Therapeutic Category:
Antilipemic
-
-