Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-01-17FDA Approved: LAMOTRIGINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
The FDA approved a supplemental application for lamotrigine filed by Unichem Pharmaceuticals (USA), Inc. This indicates a modification to th…
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FDA approval · 2020-01-17FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)
FDA approved Zydus Lifesciences Limited's original ANDA for chlorpromazine hydrochloride, a generic antipsychotic. The approval supports use…
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FDA approval · 2020-01-15FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approved a supplemental application for lamotrigine submitted by Alembic Pharmaceuticals Limited under the ANDA program.
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FDA approval · 2020-01-14FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for divalproex sodium submitted by Lupin Pharmaceuticals, Inc.
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CLINICAL_TRIALS trial_result · 2020-01-10Clinical Trial Update: SALT Study (Switching to the Administration of Lithium Slow -Release Treatment) [Phase 4]
Phase 4 clinical trial update for the SALT study evaluating switching to slow-release lithium treatment in bipolar disorder has been termina…
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FDA approval · 2020-01-09FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
The FDA approved a supplemental application for divalproex sodium submitted by Unichem Pharmaceuticals (USA), Inc.
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FDA approval · 2020-01-03FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Upsher-Smith Laboratories, LLC)
The FDA approved a supplemental application for divalproex sodium from Upsher-Smith Laboratories, indicating a regulatory action related to …
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CLINICAL_TRIALS trial_result · 2020-01-02Clinical Trial Update: A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder [Phase 3]
Phase 3 trial comparing brexpiprazole to placebo for acute manic episodes in Bipolar I Disorder has completed; results posted.
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FDA approval · 2019-12-26FDA Approved: ZIPRASIDONE MESYLATE — Original Application (Fosun Pharma USA Inc.)
FDA approved the original application for ziprasidone mesylate (generic) to treat schizophrenia and bipolar I disorder.
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FDA approval · 2019-12-26FDA Approved: ARIPIPRAZOLE — Original Application (VistaPharm, LLC)
FDA approved VistaPharm, LLC's original ANDA (212870) for a generic aripiprazole. This approval makes a generic version of aripiprazole avai…
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FDA approval · 2019-12-22FDA Approved: RISPERIDONE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)
FDA approved a supplemental application for risperidone by Jubilant Cadista Pharmaceuticals Inc. This approval pertains to changes to the ap…
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FDA approval · 2019-12-20FDA Approved: QUETIAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for quetiapine from Macleods Pharmaceuticals Limited. The action provides regulatory approval for th…
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FDA approval · 2019-12-20FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for quetiapine fumarate from Aurobindo Pharma Limited, allowing continued marketing of this generic …
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FDA approval · 2019-12-17FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)
The FDA approved a supplemental application from Alembic Pharmaceuticals Limited to manufacture and market lamotrigine chewable dispersible …
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FDA approval · 2019-12-11FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approves Hikma Pharmaceuticals USA Inc.'s supplemental application for quetiapine fumarate, a generic formulation under ANDA 090749.
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FDA approval · 2019-12-11FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for Quetiapine Fumarate (ANDA 090120).
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FDA approval · 2019-12-10FDA Approved: ARIPIPRAZOLE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for ARIPIPRAZOLE from Amneal Pharmaceuticals LLC (aripiprazole).
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CLINICAL_TRIALS trial_result · 2019-12-09Clinical Trial Update: Medication Adherence in Hypertensive Individuals With Bipolar Disorder [NA]
A completed clinical trial studied medication adherence in individuals with both hypertension and bipolar disorder; results are posted.
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FDA approval · 2019-12-06FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)
FDA approves a supplemental application for the Lamotrigine Kit from OWP Pharmaceuticals, Inc., adding a lamotrigine kit product under an ap…
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FDA approval · 2019-12-06FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for lamotrigine from Aurobindo Pharma Limited under ANDA090401, indicating an updated or added appro…
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FDA approval · 2019-12-06FDA Approved: LAMOTRIGINE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for Lamotrigine from Ascend Laboratories, LLC.
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CLINICAL_TRIALS trial_result · 2019-12-05Clinical Trial Update: Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study) [Phase 4]
Phase 4 trial comparing olanzapine to lithium for acute depression in bipolar disorder completed.
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FDA label_change · 2019-12-04FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)
FDA approved a supplemental application for LATUDA (lurasidone hydrochloride) from Sumitomo Pharma America, Inc.
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CLINICAL_TRIALS trial_result · 2019-12-02Clinical Trial Update: Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI [Phase 4]
Phase 4 trial investigating differentiating unipolar and bipolar depression in young adults using fMRI has completed with results posted.
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FDA approval · 2019-11-29FDA Approved: ZIPRASIDONE — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for ziprasidone submitted by Dr. Reddy's Laboratories Limited.