Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2010-06-22Clinical Trial Update: Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder [Phase 4]
Phase 4 trial evaluating Equetro (carbamazepine extended-release) for mania in children aged 6-12 with bipolar disorder has completed.
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FDA approval · 2010-05-28FDA Approved: VALPROIC ACID — Original Application (QUAGEN PHARMACEUTICALS LLC)
The FDA approved a generic version of valproic acid from Quagen Pharmaceuticals LLC under an Original Abbreviated New Drug Application.
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FDA approval · 2010-05-27FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for Carbamazepine submitted by Torrent Pharmaceuticals Limited.
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FDA approval · 2010-05-27FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for ZYPREXA INTRAMUSCULAR (olanzapine) from Eli Lilly and Company.
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FDA approval · 2010-05-27FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for ZYPREXA ZYDIS (olanzapine) submitted by Eli Lilly and Company.
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CLINICAL_TRIALS trial_result · 2010-05-26Clinical Trial Update: Study of Divalproex Extended Release Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to-Severe Hypomania or Mild Mania [Phase 3]
This clinical trial update indicates completion of a Phase 3 study evaluating divalproex extended-release as monotherapy for ambulatory bipo…
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FDA label_change · 2010-05-14FDA Approved: LAMOTRIGINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for lamotrigine from Sun Pharmaceutical Industries, resulting in labeling changes for the drug.
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FDA approval · 2010-04-27FDA Approved: RISPERIDONE — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a supplemental application for risperidone from ANI Pharmaceuticals, Inc., under an ANDA.
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CLINICAL_TRIALS trial_result · 2010-04-16Clinical Trial Update: 40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786) [Phase 3]
Phase 3 trial evaluating the safety of adding asenapine to lithium or valproate in bipolar disorder has completed with results posted in 201…
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CLINICAL_TRIALS trial_result · 2010-03-25Clinical Trial Update: An Open-label Trial of Metformin for Weight Control of Pediatric Patients on Antipsychotic Medications. [Phase 4]
This update notes the completion of an open-label Phase 4 trial evaluating metformin for weight control in pediatric patients on antipsychot…
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CLINICAL_TRIALS trial_result · 2010-03-24Clinical Trial Update: The Effects of Aripiprazole on Patients With Metabolic Syndrome [Phase 4]
Phase 4 trial update assessing the effects of aripiprazole in patients with metabolic syndrome. The study involves conditions including schi…
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FDA approval · 2010-03-15FDA Approved: VALPROIC ACID — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)
FDA approved the supplemental application for Valproic Acid filed by PAI Holdings dba PAI Pharma.
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CLINICAL_TRIALS withdrawal · 2010-02-24Clinical Trial Update: Safety Study of Depakote Versus Lithium in African Americans With Bipolar Disorder [Phase 4]
A Phase 4 safety study comparing Depakote (divalproex sodium) to Lithium in African American patients with Bipolar Disorder was withdrawn.
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FDA approval · 2010-02-23FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved the Supplemental Application for lamotrigine by Aurobindo Pharma Limited, resulting in approval of a generic lamotrigine produc…
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FDA approval · 2010-02-23FDA Approved: LAMOTRIGINE — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for Lamotrigine from Dr. Reddy's Laboratories Limited.
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FDA approval · 2010-02-23FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for lamotrigine filed by Zydus Pharmaceuticals USA Inc., authorizing changes to the approved pro…
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FDA approval · 2010-02-23FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries, Inc.'s supplemental application for carbamazepine (generic).
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CLINICAL_TRIALS trial_result · 2010-02-23Clinical Trial Update: Adjunctive Ziprasidone in the Treatment of Bipolar I Depression [Phase 3]
Phase 3 clinical trial update evaluating adjunctive Ziprasidone for Bipolar I Depression has completed; results were posted in 2010.
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FDA approval · 2010-02-19FDA Approved: RISPERIDONE — Supplemental Application (Westminster Pharmaceuticals, LLC)
FDA approved Westminster Pharmaceuticals, LLC's supplemental application for risperidone (ANDA 078707). This action represents an approval r…
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FDA approval · 2010-02-17FDA Approved: VALPROATE SODIUM — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved the original ANDA for valproate sodium, a generic anticonvulsant.
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CLINICAL_TRIALS trial_result · 2010-02-15Clinical Trial Update: Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder [Phase 3]
This ClinicalTrials.gov update reports the completion and posted results of a Phase 3 trial evaluating olanzapine for manic or mixed episode…
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CLINICAL_TRIALS trial_result · 2010-02-08Clinical Trial Update: A Study Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET (Positron Emission Tomography) [Phase 1]
Phase 1 PET study evaluating kappa opioid receptor occupancy of PF-04455242 in bipolar disorder and depression has been terminated. Sponsore…
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CLINICAL_TRIALS trial_result · 2010-02-03Clinical Trial Update: Taurine in Adolescents With Bipolar Disorder [Phase 1]
A Phase 1 trial evaluating taurine in adolescents with bipolar disorder has been terminated.
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FDA approval · 2010-01-27FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for Zyprexa Intramuscular (olanzapine) submitted by Eli Lilly.
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FDA approval · 2010-01-27FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)
FDA approved a supplemental application for ZYPREXA ZYDIS (olanzapine) submitted by Eli Lilly and Company.