Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2024-03-27Clinical Trial Update: Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated) [Phase 2]
Investigator-initiated Phase 2 trial evaluating Saxenda (liraglutide) for weight management in adults with stable bipolar disorder. The stud…
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FDA approval · 2024-03-21FDA Approved: PALIPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal's supplemental application for Paliperidone, enabling the marketing of a generic paliperidone product. This is an admini…
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FDA approval · 2024-03-18FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for Depakote ER (divalproex sodium) submitted by AbbVie Inc.
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FDA approval · 2024-03-18FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)
FDA approved AbbVie's supplemental application for Depakote Sprinkles (divalproex sodium).
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FDA approval · 2024-03-18FDA Approved: LITHIUM — Original Application (Saptalis Pharmaceuticals, LLC)
FDA approved Saptalis Pharmaceuticals' generic lithium product under an original ANDA.
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FDA approval · 2024-03-15FDA Approved: ARIPIPRAZOLE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for aripiprazole submitted by Chartwell RX, LLC, indicating regulatory approval of a supplement rela…
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FDA approval · 2024-03-12FDA Approved: OLANZAPINE — Supplemental Application (Aurobindo Pharma Limited)
This FDA document relates to a supplemental application for the generic antipsychotic olanzapine from Aurobindo Pharma Limited. The action p…
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FDA approval · 2024-03-11FDA Approved: QUETIAPINE — Supplemental Application (Solco Healthcare U.S., LLC)
FDA approved a supplemental application for a generic version of quetiapine, enabling Solco Healthcare U.S., LLC to market a generic quetiap…
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EMA approval · 2024-03-08EMA Authorised: Zalasta (olanzapine) — Krka
Krka-licensed olanzapine (Zalasta) has been authorised in the EU for schizophrenia and bipolar disorder.
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FDA approval · 2024-03-05FDA Approved: RISPERIDONE — Supplemental Application (Solco Healthcare US, LLC)
The FDA approved a supplemental application for risperidone filed by Solco Healthcare US, LLC.
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FDA approval · 2024-03-05FDA Approved: RISPERIDONE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for risperidone from Chartwell RX, LLC, authorizing the generic product under the approved label.
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CLINICAL_TRIALS trial_result · 2024-02-08Clinical Trial Update: Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder [Phase 3]
A Phase 3 clinical trial comparing lithium versus divalproex for treating pediatric bipolar disorder has completed enrollment and results.
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CLINICAL_TRIALS trial_result · 2024-02-07Clinical Trial Update: Augmenting Hospitalization for Serious Mental Illness: Cognitive Bias Modification [NA]
A completed clinical trial evaluating cognitive bias modification as an adjunctive treatment for serious mental illness. Results have been p…
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FDA approval · 2024-01-29FDA Approved: CARBAMAZEPINE — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a supplemental application for carbamazepine submitted by ANI Pharmaceuticals, Inc.
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FDA approval · 2024-01-29FDA Approved: CARBAMAZEPINE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application to permit Chartwell RX, LLC to market a generic carbamazepine product under an ANDA.
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FDA approval · 2024-01-29FDA Approved: CARBAMAZEPINE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)
FDA approved a supplemental application for carbamazepine from Zydus Pharmaceuticals (USA) Inc., updating the approved generic product.
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FDA approval · 2024-01-29FDA Approved: CARBAMAZEPINE — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for carbamazepine by Rising Pharma Holdings, Inc.
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EMA safety_alert · 2024-01-26Precautionary measures to address potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines
EMA safety precautionary measures advise restricting valproate use in men prior to conception due to possible risk of neurodevelopmental dis…
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CLINICAL_TRIALS trial_result · 2024-01-19Clinical Trial Update: NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation [Phase 3]
Phase 3 trial update for NRX-101 as maintenance treatment in severe bipolar depression with suicidal ideation.
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FDA approval · 2024-01-16FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for a combined olanzapine and fluoxetine product, submitted by Par Health USA, LLC (brand name Symby…
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FDA approval · 2024-01-09FDA Approved: CARBAMAZEPINE — Supplemental Application (Upsher-Smith Laboratories, LLC)
FDA approved a supplemental application for carbamazepine by Upsher-Smith Laboratories, with changes to its approved labeling and indication…
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FDA approval · 2023-12-27FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for divalproex sodium from Aurobindo Pharma Limited under an ANDA.
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FDA approval · 2023-12-22FDA Approved: CARBAMAZEPINE — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)
FDA approved a supplemental application for Carbamazepine from NIVAGEN Pharmaceuticals, authorizing changes to the generic product under the…
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CLINICAL_TRIALS trial_result · 2023-12-15Clinical Trial Update: Brain Insulin Resistance in Mood Disorders [Phase 1, Phase 2]
Clinical trial update on intranasal insulin targeting brain insulin resistance in mood disorders, spanning Phase 1 and Phase 2 for major dep…
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CLINICAL_TRIALS trial_result · 2023-12-14Clinical Trial Update: The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Bipolar Disorder I or II This Study is Not Being Conducted in the United States. [Phase 4]
Phase 4 trial evaluating oral oxcarbazepine as adjuvant therapy for bipolar disorder I or II (not conducted in the United States) has comple…