Bipolar Disorder

FDA approval · 2008-07-29

FDA Approved: DIVALPROEX SODIUM — Original Application (Lupin Pharmaceuticals, Inc.)

FDA approved Lupin Pharmaceuticals' generic divalproex sodium (Original Application), enabling a generic version of the reference product.

FDA approval · 2008-07-29

FDA Approved: DIVALPROEX SODIUM — Original Application (Sun Pharmaceutical Industries, Inc.)

FDA approved Sun Pharmaceutical Industries' divalproex sodium as an original ANDA (generic) application.

FDA approval · 2008-07-29

FDA Approved: DIVALPROEX SODIUM — Original Application (Dr.Reddy's Laboratories Limited)

FDA approved a generic version of divalproex sodium from Dr. Reddy's Laboratories Limited under an Original Application (ANDA).

FDA approval · 2008-07-28

FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)

FDA approved Apotex Corp.'s supplemental application for carbamazepine (generic), signifying approval of a supplemental ANDA for this produc…

CLINICAL_TRIALS trial_result · 2008-06-04

Clinical Trial Update: Quetiapine (Seroquel) Maintenance Treatment in Early Onset Bipolar Spectrum Disorders [Phase 3]

A Phase 3 trial evaluated quetiapine (Seroquel) for maintenance treatment in early-onset bipolar spectrum disorders; the study has completed…

FDA approval · 2008-05-21

FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

The FDA approved a supplemental application for SEROQUEL XR (quetiapine) from AstraZeneca Pharmaceuticals LP.

CLINICAL_TRIALS trial_result · 2008-05-19

Clinical Trial Update: Early Recovery Adherence Therapy for Bipolar Alcoholics [NA]

This document reports that a clinical trial evaluating Early Recovery Adherence Therapy for individuals with bipolar disorder and alcohol us…

FDA approval · 2008-05-16

FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

The FDA approved a supplemental application for Geodon (ziprasidone mesylate) submitted by Viatris Specialty LLC.

FDA approval · 2008-05-16

FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

The FDA approved a supplemental application for GEODON (ziprasidone) submitted by Viatris Specialty LLC.

CLINICAL_TRIALS trial_result · 2008-05-06

Clinical Trial Update: Safety and Efficacy of MEM 1003 Versus Placebo for the Treatment of Patients With Bipolar I Disorder [Phase 2]

Phase 2 trial results comparing MEM 1003 to placebo in Bipolar I Disorder, reporting safety and efficacy findings.

FDA approval · 2008-04-28

FDA Approved: LITHIUM — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

The FDA approved a supplemental application for Lithium from PAI Holdings dba PAI Pharma, updating an already-approved product under the AND…

FDA approval · 2008-04-21

FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

FDA approved a supplemental application for carbamazepine from Sun Pharmaceutical Industries, Inc., updating the approved generic product un…

FDA approval · 2008-04-17

FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

The FDA approved a supplemental application for carbamazepine submitted by Sun Pharmaceutical Industries, Inc.

CLINICAL_TRIALS trial_result · 2008-04-10

Clinical Trial Update: SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I Patients [Phase 2]

A Phase 2 trial comparing valproate–amisulpride versus valproate–haloperidol in patients with Bipolar I disorder has completed.

CLINICAL_TRIALS trial_result · 2008-04-01

Clinical Trial Update: Methylene Blue for Cognitive Dysfunction in Bipolar Disorder [Phase 3]

A Phase 3 clinical trial evaluating methylene blue for cognitive dysfunction in bipolar disorder has completed.

FDA approval · 2008-03-24

FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

FDA has approved a supplemental application for Depakote Sprinkles (divalproex sodium) from AbbVie.

FDA approval · 2008-03-24

FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

FDA approved a supplemental application for Depakote ER (divalproex sodium) submitted by AbbVie. The approval covers changes to Depakote ER'…

CLINICAL_TRIALS trial_result · 2008-03-24

Clinical Trial Update: Antidepressant Therapy for Bipolar II Major Depression [Phase 4]

Phase 4 trial update showing completed evaluation of antidepressant therapy for major depression in Bipolar II disorder.

CLINICAL_TRIALS trial_result · 2008-03-18

Clinical Trial Update: Injectable Versus Oral Naltrexone Treatment of Alcohol Dependence In Serious Mental Illness (SMI) [Phase 4]

Phase 4 trial comparing injectable versus oral naltrexone for alcohol dependence in people with serious mental illness has completed.

CLINICAL_TRIALS trial_result · 2008-03-07

Clinical Trial Update: Safety And Efficacy Study Of Depakote ER To Treat Pediatric Bipolar Disorder [Phase 4]

Phase 4 safety and efficacy study of Depakote ER in pediatric bipolar disorder has completed.