Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-11-09FDA Approved: LAMOTRIGINE — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for Lamotrigine from Torrent Pharmaceuticals Limited, authorizing a modification to the approved gen…
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FDA approval · 2021-11-03FDA Approved: OLANZAPINE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for olanzapine from Aurobindo Pharma Limited under ANDA 203708, finalizing approval of a generic…
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FDA approval · 2021-11-02FDA Approved: ZIPRASIDONE — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approves a supplemental application for ZIPRASIDONE from Dr. Reddy's Laboratories Limited, indicating the approval of a generic version …
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FDA approval · 2021-11-02FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved a supplemental application for Quetiapine Fumarate from Unichem Pharmaceuticals (USA), Inc. The action approves changes to the …
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FDA approval · 2021-11-01FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for a generic quetiapine fumarate product from Aurobindo Pharma Limited, enabling its use as a g…
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FDA approval · 2021-10-29FDA Approved: LAMOTRIGINE — Supplemental Application (Advagen Pharma Limited)
The FDA approved Advagen Pharma Limited's supplemental application for lamotrigine, confirming approval of the requested changes to this gen…
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FDA approval · 2021-10-25FDA Approved: LURASIDONE HYDROCHLORIDE — Supplemental Application (Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approves a supplemental application for lurasidone hydrochloride by Heritage Pharma Labs (Avet) under an ANDA, enabling continued or exp…
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FDA approval · 2021-08-31FDA Approved: RISPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approves a supplemental application for risperidone by Amneal Pharmaceuticals LLC. This action represents a supplemental approval under …
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CLINICAL_TRIALS trial_result · 2021-08-27Clinical Trial Update: Texting to Improve Adherence in HIV+ With Bipolar Disorder [NA]
Completed clinical trial studying texting to improve adherence in people with HIV and bipolar disorder; results posted in 2021.
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FDA label_change · 2021-07-19FDA Approved: ASENAPINE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approved a supplemental application for asenapine from Alembic Pharmaceuticals Limited, resulting in updated labeling for the drug.
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FDA approval · 2021-07-19FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for ziprasidone hydrochloride from Apotex Corp., enabling the marketing of a generic version of the …
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FDA approval · 2021-07-19FDA Approved: QUETIAPINE EXTENDED-RELEASE — Supplemental Application (AlignScience Pharma Inc.)
FDA approved AlignScience Pharma Inc.'s supplemental application for quetiapine extended-release, enabling its marketing as a generic produc…
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CLINICAL_TRIALS trial_result · 2021-07-02Clinical Trial Update: Cannabidiol as an Adjunctive Treatment for Bipolar Depression [Phase 2, Phase 3]
A phase 2/3 clinical trial evaluating cannabidiol as an adjunctive treatment for bipolar depression was terminated.
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CLINICAL_TRIALS trial_result · 2021-06-24Clinical Trial Update: Lithium for Suicidal Behavior in Mood Disorders [Phase 2, Phase 3]
The clinical trial update covers lithium for suicidal behavior in mood disorders across Phase 2 and Phase 3. The study has been terminated a…
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FDA approval · 2021-06-02FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Sandoz, Inc.)
FDA approved chlorpromazine hydrochloride as a generic drug through an original ANDA submitted by Sandoz, Inc.
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FDA approval · 2021-05-28FDA Approved: LYBALVI — Original Application (Alkermes, Inc.)
FDA approved LYBALVI (olanzapine and samidorphan L-malate) from Alkermes as an original drug application. It is indicated for the treatment …
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CLINICAL_TRIALS trial_result · 2021-05-25Clinical Trial Update: Treating Smokers With Mental Illness [Phase 2]
Phase 2 clinical trial assessing treatments for smoking cessation in individuals with mental illness; study completed with posted results in…
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FDA approval · 2021-05-18FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Geodon (ziprasidone mesylate) filed by Viatris Specialty LLC.
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FDA approval · 2021-05-18FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Geodon (ziprasidone) submitted by Viatris Specialty LLC.
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FDA approval · 2021-05-13FDA Approved: LURASIDONE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)
FDA approves Alembic Pharmaceuticals' generic Lurasidone hydrochloride tablets under an Original Application (ANDA213248). Lurasidone is use…
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CLINICAL_TRIALS trial_result · 2021-04-27Clinical Trial Update: Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder [Phase 3]
An extension Phase 3 trial assessing safety and tolerability of flexible doses of oral ziprasidone in children and adolescents with Bipolar …
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FDA approval · 2021-04-23FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for divalproex sodium from Aurobindo Pharma Limited, a generic formulation.
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FDA approval · 2021-04-13FDA Approved: CARBAMAZEPINE — Original Application (Upsher-Smith Laboratories, LLC)
FDA approved Upsher-Smith Laboratories' Original Application for carbamazepine (generic) under ANDA213311.
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CLINICAL_TRIALS trial_result · 2021-04-01Clinical Trial Update: Prediction of Clinical Response to SSRI Treatment in Bipolar Disorder Using Serotonin 1A Receptor PET Imaging [Phase 4]
Phase 4 clinical trial evaluating whether serotonin 1A receptor PET imaging can predict response to SSRI treatment in bipolar disorder; resu…
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CLINICAL_TRIALS trial_result · 2021-04-01Clinical Trial Update: Efficacy and Safety of Peropirone Hydrochloride Tablets in the Treatment of Adolescent Bipolar Disorder Depression [Phase 4]
Phase 4 trial update evaluating efficacy and safety of Peropirone Hydrochloride tablets for depressive disorders in adolescents.