Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-03-31FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental application for LAMICTAL ODT (lamotrigine) submitted by GlaxoSmithKline, updating its regulatory status for …
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CLINICAL_TRIALS trial_result · 2021-03-18Clinical Trial Update: Wake Therapy in the Treatment of Depression [NA]
Clinical trial update for wake therapy in depression completed; results posted in 2021.
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FDA approval · 2021-03-10FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Lamotrigine from Zydus Pharmaceuticals USA Inc., indicating an update to its labeling/indica…
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FDA approval · 2021-03-09FDA Approved: ASENAPINE — Original Application (Breckenridge Pharmaceutical, Inc.)
FDA approved a generic version of asenapine (asenapine maleate) from Breckenridge Pharmaceutical, Inc. via an Original Application (ANDA2059…
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FDA approval · 2021-02-26FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva's supplemental application for the generic olanzapine/fluoxetine combination, expanding access to this treatment.
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FDA approval · 2021-02-26FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's supplemental application for a generic olanzapine and fluoxetine product. The combination is indicated for depressive ep…
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CLINICAL_TRIALS withdrawal · 2021-02-21Clinical Trial Update: Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) [Phase 3]
A Phase 3 trial evaluating safety and tolerability of flexible doses of oral ziprasidone in children and adolescents with Bipolar I Disorder…
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CLINICAL_TRIALS trial_result · 2021-02-21Clinical Trial Update: A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders [Phase 2]
Phase 2 trial update evaluating the safety and tolerability of oral ziprasidone in children and adolescents with psychotic disorders complet…
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CLINICAL_TRIALS withdrawal · 2021-02-21Clinical Trial Update: Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196) [Phase 3]
A Phase 3 trial evaluating ziprasidone for bipolar I disorder in children and adolescents has been withdrawn.
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CLINICAL_TRIALS withdrawal · 2021-02-21Clinical Trial Update: Suvorexant (Belsomra) for the Treatment of Bipolar Depression With Insomnia [Phase 4]
A Phase 4 trial of suvorexant (Belsomra) for bipolar depression with insomnia has been withdrawn.
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FDA approval · 2021-02-12FDA Approved: RISPERIDONE — Supplemental Application (Janssen Pharmaceutical, Inc.)
The FDA approved Janssen's supplemental application for risperidone, resulting in changes to its labeling/indications.
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FDA approval · 2021-02-10FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental NDA for Depakote (divalproex sodium) submitted by AbbVie Inc.
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FDA approval · 2021-02-04FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Par Health USA, LLC)
The FDA approved a supplemental application for a generic fixed-dose combination of olanzapine and fluoxetine from Par Health USA, LLC. The …
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FDA approval · 2021-02-01FDA Approved: ARIPIPRAZOLE — Supplemental Application (Alembic Pharmaceuticals Inc.)
FDA approved a supplemental application for ARIPIPRAZOLE from Alembic Pharmaceuticals Inc., authorizing a generic aripiprazole product. The …
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FDA approval · 2021-02-01FDA Approved: ARIPIPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Inc)
FDA approves Dr. Reddy's Laboratories' supplemental application to add a generic aripiprazole orally disintegrating tablet.
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FDA approval · 2021-01-22FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Lannett Company, Inc.)
FDA approved Lannett's generic chlorpromazine hydrochloride (ANDA 212996), authorizing the marketing of a generic chlorpromazine hydrochlori…
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FDA approval · 2021-01-19FDA Approved: LAMOTRIGINE — Original Application (Ajanta Pharma USA Inc.)
FDA approves Ajanta Pharma USA Inc.'s original ANDA for lamotrigine, authorizing sale of a generic lamotrigine product for the same indicati…
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CLINICAL_TRIALS trial_result · 2021-01-13Clinical Trial Update: Treating Insulin Resistance as a Strategy to Improve Outcome in Refractory Bipolar Disorder [Phase 3]
Phase 3 clinical trial investigating treating insulin resistance to improve outcomes in refractory bipolar disorder has completed.
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FDA approval · 2020-12-31FDA Approved: OLANZAPINE — Original Application (Hisun Pharmaceuticals USA, Inc.)
FDA approved a generic olanzapine product under Hisun Pharmaceuticals USA, Inc.'s Original Application for olanzapine.
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FDA approval · 2020-12-31FDA Approved: OLANZAPINE — Original Application (Hisun Pharmaceuticals USA, Inc.)
FDA approved the original abbreviated new drug application for olanzapine, a generic form manufactured by Hisun Pharmaceuticals USA, for use…
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FDA approval · 2020-12-10FDA Approved: ASENAPINE — Original Application (Alembic Pharmaceuticals Limited)
The FDA approved Alembic Pharmaceuticals Limited's original ANDA for asenapine, enabling a generic version of the drug to be marketed.
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FDA approval · 2020-12-10FDA Approved: ASENAPINE — Original Application (Sigmapharm Laboratories, LLC)
FDA approved Sigmapharm Laboratories, LLC's original (ANDA) application for asenapine, enabling a generic version to enter the market. The a…
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FDA approval · 2020-12-10FDA Approved: ASENAPINE — Original Application (Breckenridge Pharmaceutical, Inc.)
FDA approved Breckenridge Pharmaceutical's original application for a generic asenapine maleate product. The generic is intended for the sam…
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FDA approval · 2020-11-17FDA Approved: RISPERIDONE — Supplemental Application (Solco Healthcare US, LLC)
The FDA approved Solco Healthcare US, LLC's supplemental application to market a generic risperidone product.
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FDA approval · 2020-11-16FDA Approved: OLANZAPINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for Teva Pharmaceuticals' olanzapine product under an ANDA.