Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2022-12-21Clinical Trial Update: Restoration of Cognitive Function With TDCS and Training in Serious Mental Illness [NA]
Completed clinical trial investigating transcranial direct current stimulation (TDCS) plus training to restore cognitive function in serious…
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EMA approval · 2022-12-20EMA Authorised: Olanzapine Glenmark Europe (olanzapine) — Glenmark Arzneimittel GmbH
Authorised olanzapine product (Glenmark Europe) for schizophrenia and bipolar disorder.
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EMA approval · 2022-12-20EMA Authorised: Olanzapine Glenmark (olanzapine) — Glenmark Arzneimittel GmbH
Glenmark's olanzapine product has been authorised for schizophrenia and bipolar disorder in the EU.
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FDA approval · 2022-12-13FDA Approved: LURASIDONE HYDROCHLORIDE — Original Application (Ascend Laboratories, LLC)
FDA approved lurasidone hydrochloride tablets as a generic Original Application for the treatment of schizophrenia and depressive episodes a…
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FDA label_change · 2022-12-02FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)
FDA approved Janssen's supplemental application for Risperdal M-TAB (risperidone), updating labeling and introducing the M-TAB dosage form.
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FDA approval · 2022-12-02FDA Approved: CARBAMAZEPINE — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approved the original application for a generic carbamazepine product from Ingenus Pharmaceuticals, LLC.
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CLINICAL_TRIALS trial_result · 2022-11-22Clinical Trial Update: Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients [Phase 4]
A Phase 4 trial evaluating a fixed-dose intervention to enhance survival in patients with serious mental illness, including schizophrenia an…
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FDA approval · 2022-11-21FDA Approved: EPITOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for EPITOL (carbamazepine) from Teva Pharmaceuticals USA, Inc. This action approves changes to the p…
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FDA approval · 2022-11-16FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for divalproex sodium, authorizing changes to the approved generic product unde…
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FDA approval · 2022-11-09FDA Approved: CARBAMAZEPINE — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a supplemental application for carbamazepine filed by ANI Pharmaceuticals, Inc.
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FDA approval · 2022-11-08FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)
The FDA approved a supplemental application for Carbamazepine submitted by Apotex Corp., a generic formulation.
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FDA approval · 2022-11-08FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for carbamazepine from Apotex Corp., approving changes to the approved generic product.
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FDA approval · 2022-10-27FDA Approved: ARIPIPRAZOLE — Original Application (Advagen Pharma Ltd)
FDA approves Advagen Pharma Ltd's original application for a generic aripiprazole product.
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FDA approval · 2022-10-25FDA Approved: RISPERIDONE — Supplemental Application (Solco Healthcare US, LLC)
The FDA approved a supplemental application for risperidone submitted by Solco Healthcare US, LLC.
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FDA approval · 2022-10-25FDA Approved: ARIPIPRAZOLE — Original Application (Chartwell RX, LLC)
The FDA approved Chartwell RX, LLC's original application for a generic aripiprazole product. Aripiprazole is used to treat schizophrenia, b…
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CLINICAL_TRIALS withdrawal · 2022-10-14Clinical Trial Update: A PET Study With [11C]PBR-28 and an Experimental Medication, Ethyl Eicosapentaenoic Acid [Phase 4]
A Phase 4 clinical trial investigating Ethyl Eicosapentaenoic Acid with [11C]PBR-28 in bipolar disorder has been withdrawn.
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FDA approval · 2022-10-13FDA Approved: LITHOBID — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Lithobid (lithium carbonate) filed by ANI Pharmaceuticals, Inc.
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FDA approval · 2022-10-13FDA Approved: LITHIUM CARBONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for lithium carbonate from Hikma Pharmaceuticals USA Inc., authorizing changes to the existing N…
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FDA approval · 2022-10-13FDA Approved: LITHIUM CARBONATE ER — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved a supplemental application for Lithium Carbonate ER from Glenmark Pharmaceuticals, authorizing an extended-release formulat…
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FDA approval · 2022-10-13FDA Approved: LITHIUM CARBONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for lithium carbonate submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2022-10-13FDA Approved: LITHIUM CARBONATE — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for lithium carbonate filed by Rising Pharma Holdings, Inc. (ANDA205663).
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FDA label_change · 2022-10-13FDA Approved: LITHIUM — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)
The FDA approved a supplemental application for Lithium from PAI Holdings (PAI Pharma) to an already approved drug, likely resulting in labe…
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CLINICAL_TRIALS trial_result · 2022-10-12Clinical Trial Update: Families With Substance Use and Psychosis: A Pilot Study [NA]
A completed pilot study from McLean Hospital investigating families with substance use and psychosis; results posted in 2022.
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FDA approval · 2022-10-06FDA Approved: LURASIDONE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental abbreviated new drug application for lurasidone hydrochloride, enabling marketing of the ge…
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FDA approval · 2022-10-06FDA Approved: CARBAMAZEPINE — Original Application (ANI Pharmaceuticals, Inc.)
The FDA approved ANI Pharmaceuticals' generic carbamazepine under Original Application ANDA214277.