Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2015-02-20FDA Approved: OLANZAPINE — Original Application (Macleods Pharmaceuticals Limited)
FDA approved Macleods Pharmaceuticals Limited's generic olanzapine (oral) under ANDA203044. It covers indications for schizophrenia and bipo…
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FDA approval · 2015-02-18FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)
The FDA approved a supplemental application for carbamazepine filed by Apotex Corp., indicating an approved modification to the generic prod…
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FDA approval · 2015-02-18FDA Approved: LAMOTRIGINE — Supplemental Application (Advagen Pharma Limited)
FDA approved a supplemental application for lamotrigine by Advagen Pharma Limited (ANDA 078625).
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CLINICAL_TRIALS trial_result · 2015-02-12Clinical Trial Update: Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder [Phase 4]
This Phase 4 study evaluated quetiapine sustained-release as an adjunctive treatment for mixed states in bipolar disorder; results were post…
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FDA approval · 2015-02-04FDA Approved: ZIPRASIDONE — Supplemental Application (Chartwell RX, LLC)
The FDA approved a supplemental application for Ziprasidone from Chartwell RX, LLC, enabling a generic version of the antipsychotic to be ma…
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CLINICAL_TRIALS trial_result · 2015-01-26Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder [Phase 3]
Phase 3 trial evaluating armodafinil as adjunctive therapy for major depressive episodes in adults with Bipolar I disorder; results were pos…
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CLINICAL_TRIALS trial_result · 2015-01-26Clinical Trial Update: Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder [Phase 3]
A Phase 3 study evaluated armodafinil 150 mg/day as adjunctive therapy for adults with major depression associated with bipolar I disorder; …
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CLINICAL_TRIALS trial_result · 2015-01-26Clinical Trial Update: Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder [Phase 3]
Phase 3 trial evaluating armodafinil as adjunctive therapy for adults with major depressive episodes associated with bipolar I disorder has …
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CLINICAL_TRIALS trial_result · 2015-01-26Clinical Trial Update: Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder [Phase 3]
Phase 3 extension study update for armodafinil as adjunctive therapy in adults with major depression associated with Bipolar I Disorder; stu…
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FDA approval · 2015-01-20FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for Carbamazepine from Torrent Pharmaceuticals Limited, indicating an approved action on an existing…
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FDA approval · 2015-01-20FDA Approved: EPITOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for EPITOL (carbamazepine) from Teva Pharmaceuticals USA, Inc.
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FDA approval · 2015-01-20FDA Approved: OLANZAPINE — Supplemental Application (Dr. Reddy's Laboratories Inc.)
FDA approved a supplemental application for the generic olanzapine, manufactured by Dr. Reddy's Laboratories Inc.
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FDA approval · 2015-01-17FDA Approved: OLANZAPINE — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved Torrent Pharmaceuticals Limited's supplemental application for olanzapine (generic) under the ANDA pathway. This represents a s…
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CLINICAL_TRIALS trial_result · 2015-01-16Clinical Trial Update: PK Effects of Bifeprunox & Valproate in Bipolar I [Phase 2]
Phase 2 trial update examining pharmacokinetic interactions between bifeprunox and valproate in Bipolar I Disorder.
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CLINICAL_TRIALS trial_result · 2015-01-16Clinical Trial Update: Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Schizophrenia or Bipolar Disorder [Phase 2]
Phase 2 trial update examining progressively decreasing titration schedules of bifeprunox in individuals with schizophrenia or bipolar disor…
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FDA approval · 2015-01-16FDA Approved: VALPROIC ACID — Supplemental Application (QUAGEN PHARMACEUTICALS LLC)
FDA approves a supplemental application for Valproic acid from Quagen Pharmaceuticals LLC (ANDA 090517).
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FDA approval · 2015-01-12FDA Approved: RISPERIDONE — Original Application (Chartwell RX, LLC)
FDA approved Chartwell RX, LLC's generic risperidone through an original ANDA submission, marking the first approval of this generic product…
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CLINICAL_TRIALS trial_result · 2015-01-08Clinical Trial Update: Oral Uridine for Treatment of Bipolar Depression in Adolescents [Phase 2]
Phase 2 clinical trial evaluating oral uridine for bipolar depression in adolescents has completed and posted results.
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CLINICAL_TRIALS trial_result · 2015-01-08Clinical Trial Update: Evaluation of the In SHAPE Fitness Intervention for Adults With Serious Mental Illness [NA]
Clinical trial update on the In SHAPE fitness intervention for adults with serious mental illness indicates the study status is COMPLETED. T…
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CLINICAL_TRIALS trial_result · 2015-01-08Clinical Trial Update: Evaluation of A Statewide Program to Prevent Early Mortality and to Promote Fitness in Persons With SMI [NA]
This ClinicalTrials.gov update reports that the statewide program to prevent early mortality and promote fitness in persons with serious men…
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FDA approval · 2015-01-07FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for Depakote ER (divalproex sodium) filed by AbbVie Inc., resulting in a regulatory update to th…
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CLINICAL_TRIALS trial_result · 2015-01-05Clinical Trial Update: Peer Support for Severe Mental Disorders [NA]
Completed clinical trial evaluating peer support interventions for severe mental disorders, including psychosis, major depressive disorder, …
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FDA approval · 2014-12-30FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)
FDA approved a supplemental application for LAMICTAL (lamotrigine) from GlaxoSmithKline, updating the product labeling as a result of the su…
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FDA approval · 2014-12-30FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental application for LAMICTAL XR (lamotrigine) from GlaxoSmithKline LLC, updating the extended-release formulatio…
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CLINICAL_TRIALS trial_result · 2014-12-23Clinical Trial Update: Peroxisomal Defects and Familial Risk for Bipolar Disorder
A completed clinical trial from the University of Cincinnati investigated peroxisomal defects and familial risk factors for bipolar disorder…