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:
08/08/2018
Trade Name:
Jornay PM
Generic Name or Proper Name (*):
methylphenidate
Indications Studied:
Attention Deficit Hyperactivity Disorder
Label Changes Summary:
*Safety and effectiveness have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled clinical studies in pediatric patients 6 to 12 years, pharmacokinetic data in adults, and safety information from other methylphenidate-containing products. *Safety and effectiveness in pediatric patients less than 6 years have not been established. *The long-term efficacy of methylphenidate in pediatric patients has not been established. *Growth should be monitored during treatment with stimulants, including JORNAY PM. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted. *Information on dosing, adverse reactions, clinical trials. *New dosage form.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Ironshore Pharmaceuticals & Development, Inc.
NNPS:
FALSE
Therapeutic Category:
CNS Stimulant
-
-