NDAORALCAPSULE, EXTENDED RELEASE
Approved
Apr 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
10
Mechanism of Action
(CNS) stimulant. The mode of therapeutic action in ADHD is not known.
Clinical Trials (5)
Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder
Started Apr 2011
299 enrolled
Attention Deficit/Hyperactivity Disorder
Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)
Started Nov 2010
725 enrolled
Attention Deficit/Hyperactivity Disorder
Adult Study / OROS Methylphenidate Hydrochloride (HCL) (OROS MPH) in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Started Jul 2009
357 enrolled
Attention Deficit Disorder With Hyperactivity
Efficacy Study of Methylphenidate Hydrochloride to Reduce Fatigue in Prostate Cancer Patients Receiving Hormone Therapy
Started Jan 2008
33 enrolled
Prostatic NeoplasmsFatigue
A Study of Repeat Dosing of OROS® Methylphenidate Hydrochloride (CONCERTA®) and Immediate Release Methylphenidate Hydrochloride in Healthy Adults
Started Jan 2006
44 enrolled
Healthy