Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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FDA label_change · 2014-11-08FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for divalproex sodium submitted by Sun Pharmaceutical Industries to update the product labeling.
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FDA label_change · 2014-11-06FDA Approved: QUETIAPINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for quetiapine by Teva Pharmaceuticals USA, Inc., resulting in labeling updates for the product. The…
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CLINICAL_TRIALS trial_result · 2014-11-05Clinical Trial Update: Optimizing Pharmacotherapy for Bipolar Alcoholics [Phase 1, Phase 2]
A Phase 1/2 clinical trial studied optimization of pharmacotherapy for people with comorbid bipolar disorder and alcohol use disorder. The s…
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FDA approval · 2014-10-30FDA Approved: QUETIAPINE — Supplemental Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s supplemental application for quetiapine, enabling the marketing of a generic quetiapine product. The a…
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FDA approval · 2014-10-28FDA Approved: QUETIAPINE FUMARATE — Original Application (Alembic Pharmaceuticals Limited)
FDA approved Alembic Pharmaceuticals Limited's original generic application for quetiapine fumarate, a second-generation antipsychotic used …
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CLINICAL_TRIALS trial_result · 2014-10-28Clinical Trial Update: A Pilot Study Assessing EmSam in Bipolar Depression [Phase 4]
Phase 4 pilot trial evaluating EmSam for bipolar depression was terminated, with results posted in 2014.
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FDA approval · 2014-10-21FDA Approved: SAPHRIS — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for SAPHRIS (asenapine maleate) from Allergan, Inc.
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CLINICAL_TRIALS trial_result · 2014-10-17Clinical Trial Update: Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance [Phase 4]
Phase 4 clinical trial evaluating pioglitazone for bipolar disorder with comorbid metabolic syndrome or insulin resistance; results were pos…
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FDA approval · 2014-09-30FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for ZYPREXA INTRAMUSCULAR (olanzapine) by Eli Lilly and Company. The action results in changes t…
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FDA approval · 2014-09-26FDA Approved: RISPERIDONE — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved Torrent Pharmaceuticals Limited's supplemental application for risperidone (generic), enabling the marketed generic version to …
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FDA approval · 2014-09-26FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for lamotrigine from Zydus Pharmaceuticals USA Inc., resulting in updated labeling for the gener…
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FDA label_change · 2014-09-26FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approves a supplemental application for lamotrigine from Zydus Pharmaceuticals USA Inc.
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FDA approval · 2014-09-25FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for risperidone from Zydus Lifesciences Limited.
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FDA approval · 2014-09-25FDA Approved: RISPERIDONE — Supplemental Application (Westminster Pharmaceuticals, LLC)
FDA approved a supplemental application for risperidone by Westminster Pharmaceuticals, LLC to support a generic version of risperidone.
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FDA approval · 2014-09-19FDA Approved: DIVALPROEX SODIUM — Supplemental Application (BluePoint Laboratories)
FDA approves a supplemental application for Divalproex Sodium by BluePoint Laboratories, indicating clearance of a supplemental filing for a…
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FDA approval · 2014-09-16FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for Tegretol (carbamazepine) submitted by Novartis Pharmaceuticals Corporation. The action updat…
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FDA approval · 2014-09-16FDA Approved: TEGRETOL XR — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for Tegretol XR (carbamazepine) from Novartis Pharmaceuticals Corporation, resulting in updated labe…
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CLINICAL_TRIALS trial_result · 2014-09-04Clinical Trial Update: Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107) [Phase 3]
A Phase 3 trial evaluated the efficacy and safety of asenapine for pediatric bipolar disorder; the study completed and results were posted i…
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CLINICAL_TRIALS trial_result · 2014-09-04Clinical Trial Update: Effects of Pentazocine on Manic Symptoms [Phase 2]
Phase 2 trial evaluating the effects of pentazocine on manic symptoms in bipolar disorder; results posted in 2014.
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CLINICAL_TRIALS trial_result · 2014-08-26Clinical Trial Update: A Trial of SAMe for Treatment-Resistant Bipolar Depression [NA]
A completed clinical trial evaluating SAMe for treatment-resistant bipolar depression; results posted in 2014.
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CLINICAL_TRIALS trial_result · 2014-08-21Clinical Trial Update: Effects of Pentazocine Versus Lorazepam on Manic Symptoms [Phase 2]
Phase 2 trial comparing pentazocine to lorazepam for manic symptoms in bipolar and schizoaffective disorders; results posted after completio…
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CLINICAL_TRIALS trial_result · 2014-08-21Clinical Trial Update: An Epidemiological Registry Study to Evaluate Clinical Practice Treatment in Patients With Bipolar Disorder
This entry notes the completion of an epidemiological registry study assessing real-world clinical practice treatment for Bipolar Disorder, …
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FDA approval · 2014-08-15FDA Approved: OLANZAPINE — Original Application (Macleods Pharmaceuticals Limited)
FDA approved Macleods Pharmaceuticals Limited's generic olanzapine under an Original Application (ANDA).
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CLINICAL_TRIALS trial_result · 2014-08-12Clinical Trial Update: Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity
This completed trial from Massachusetts General Hospital examined predictors of maternal and neonatal morbidity in bipolar disorder during p…
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FDA approval · 2014-08-11FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for ZYPREXA INTRAMUSCULAR (olanzapine) submitted by Eli Lilly and Company.