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:
08/16/2016
Trade Name:
Kapvay
Generic Name or Proper Name (*):
clonidine
Indications Studied:
Postmarketing study
Label Changes Summary:
*In studies in juvenile rats, clonidine hydrochloride alone or in combination with methylphenidate had an effect on bone growth at clinically relevant doses and produced a slight delay in sexual maturation in males at 3 times the maximum recommended human dose (MRHD) for clonidine and methylphenidate. *Juvenile rat studies also showed a decrease in bone mineral density, mineral content, and decreased femur length. Decreased body weight was also observed. *Postmarketing study.
PREA(P):
P
Sponsor:
Concordia Pharmaceuticals, Inc.
NNPS:
FALSE
Therapeutic Category:
Non-stimulant ADHD treatment
-
-