Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2023-12-13Clinical Trial Update: Imaging GABAergic/Glutamatergic Drugs in Bipolar Alcoholics Alcoholics [Phase 2]
Phase 2 trial update on imaging GABAergic/Glutamatergic drugs for comorbid alcohol use disorder and bipolar disorder; study completed with r…
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FDA approval · 2023-12-11FDA Approved: CARBAMAZEPINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
The FDA approved a supplemental application for carbamazepine filed by Unichem Pharmaceuticals (USA), Inc., signaling an approved change to …
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FDA approval · 2023-12-05FDA Approved: RISPERIDONE — Original Application (Teva Pharmaceuticals, Inc.)
FDA approved Teva Pharmaceuticals' generic risperidone as an original application (ANDA214068).
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FDA approval · 2023-11-22FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Bionpharma Inc.)
FDA approved a supplemental application for divalproex sodium submitted by Bionpharma Inc. under an ANDA.
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CLINICAL_TRIALS trial_result · 2023-11-18Clinical Trial Update: A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder [Phase 1, Phase 2]
A multi-dose aripiprazole trial in adults with schizophrenia or Bipolar I Disorder has completed phases 1 and 2, with results posted in 2023…
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FDA approval · 2023-11-01FDA Approved: UZEDY — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for UZEDY (risperidone) from Teva Pharmaceuticals USA, Inc.
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FDA approval · 2023-11-01FDA Approved: ARIPIPRAZOLE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' generic oral aripiprazole under an original ANDA.
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FDA approval · 2023-10-24FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Supplemental Application (BluePoint Laboratories)
The FDA approved a supplemental application for ziprasidone hydrochloride from BluePoint Laboratories, granting ANDA-based approval of a gen…
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FDA approval · 2023-10-23FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for divalproex sodium from Mylan Pharmaceuticals, indicating regulatory authorization for a generic …
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CLINICAL_TRIALS trial_result · 2023-10-23Clinical Trial Update: Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder [Phase 4]
Phase 4 clinical trial evaluating sublingual dexmedetomidine for moderate to severe agitation in inpatients with schizophrenia or bipolar di…
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FDA approval · 2023-10-06FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for divalproex sodium from Sun Pharmaceutical Industries, Inc.
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FDA approval · 2023-10-06FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Upsher-Smith Laboratories, LLC)
FDA approved a supplemental application for divalproex sodium from Upsher-Smith Laboratories, LLC.
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CLINICAL_TRIALS trial_result · 2023-09-28Clinical Trial Update: A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features [Phase 3]
A Phase 3 trial evaluating cariprazine for preventing relapse in Bipolar I Disorder patients currently in manic or depressive episodes (with…
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FDA approval · 2023-09-26FDA Approved: DIVALPROEX SODIUM — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' original ANDA for divalproex sodium, providing a generic option for this anticonvulsant/mood stabilizer…
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FDA approval · 2023-09-25FDA Approved: LYBALVI — Supplemental Application (Alkermes, Inc.)
FDA approved a supplemental application for LYBALVI (olanzapine and samidorphan L-malate) from Alkermes. The action pertains to changes to t…
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FDA approval · 2023-09-19FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Accord Healthcare Inc.)
FDA approves Accord Healthcare's supplemental application to market quetiapine fumarate as a generic drug.
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FDA approval · 2023-09-18FDA Approved: RISPERIDONE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)
FDA approved a supplemental application for risperidone by Jubilant Cadista Pharmaceuticals Inc., updating/expanding its approval for risper…
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FDA approval · 2023-09-13FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for Tegretol (carbamazepine) filed by Novartis Pharmaceuticals Corporation.
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CLINICAL_TRIALS trial_result · 2023-09-11Clinical Trial Update: Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder [Phase 3]
Phase 3 trial investigating dexmedetomidine for agitation associated with bipolar disorder has completed with results posted.
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CLINICAL_TRIALS trial_result · 2023-09-11Clinical Trial Update: Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder [Phase 3]
Phase 3 clinical trial evaluating dexmedetomidine for agitation associated with bipolar disorder has completed and results were posted.
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FDA label_change · 2023-08-25FDA Approved: LITHIUM CARBONATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved a supplemental application for the generic lithium carbonate from Glenmark Pharmaceuticals, likely to update the product’s …
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FDA approval · 2023-08-14FDA Approved: LITHIUM — Original Application (Advagen Pharma Ltd)
FDA approves Advagen Pharma Ltd's generic lithium carbonate product under an Original Application (ANDA 218036).
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FDA approval · 2023-08-08FDA Approved: RISPERIDONE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for risperidone from Aurobindo Pharma Limited, authorizing a generic risperidone product under ANDA …
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FDA approval · 2023-08-08FDA Approved: ZIPRASIDONE MESYLATE — Supplemental Application (Fosun Pharma USA Inc.)
FDA approved a supplemental application for ziprasidone mesylate, a salt form of ziprasidone, submitted by Fosun Pharma USA Inc.
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FDA approval · 2023-07-31FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for divalproex sodium by Lupin Pharmaceuticals, Inc. under ANDA 078790.