NDAORALTABLET, EXTENDED RELEASEPriority Review
Approved
Mar 2008
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Mechanism of Action
tract. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid (GABA).
Indications (12)
Clinical Trials (5)
Quetiapine SR and Divalproex Sodium ER in the Treatment of Anxiety in Bipolar Disorder With Panic Disorder and/or GAD
Started Jul 2007
224 enrolled
Bipolar DisorderPanic DisorderGeneralized Anxiety Disorder
Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions
Started Oct 2006
28 enrolled
Seizures
Divalproex Sodium 500 mg Extended Release Tablets Under Non-Fasting Conditions
Started Oct 2006
24 enrolled
Healthy
Divalproex Sodium 500 mg Extended Release Tablets Under Fasting Conditions
Started Aug 2006
48 enrolled
Healthy
A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR
Started Jun 2006
5 enrolled
ManiaMixed Mania