Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-11-29FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for ziprasidone hydrochloride from BluePoint Laboratories, authorizing its generic product to be mar…
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FDA approval · 2019-11-22FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application to introduce Depakote Sprinkles (divalproex sodium) from AbbVie, expanding the drug's dosage form op…
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FDA approval · 2019-11-22FDA Approved: QUETIAPINE — Supplemental Application (Accord Healthcare Inc.)
FDA approves a supplemental application for Quetiapine by Accord Healthcare Inc., granting regulatory approval for a generic version of the …
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FDA approval · 2019-11-21FDA Approved: LAMOTRIGINE — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for lamotrigine by Torrent Pharmaceuticals Limited.
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FDA approval · 2019-11-21FDA Approved: LAMOTRIGINE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for lamotrigine from Actavis Pharma, Inc.
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CLINICAL_TRIALS trial_result · 2019-11-20Clinical Trial Update: The Family VOICE Study [NA]
Completed clinical trial (The Family VOICE Study) with results posted in 2019; conditions include autism and aggression among others listed.
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FDA approval · 2019-11-12FDA Approved: RISPERIDONE — Supplemental Application (Ajanta Pharma USA Inc.)
The FDA approved Ajanta Pharma USA Inc.'s supplemental application for risperidone, authorizing a generic version of the antipsychotic.
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CLINICAL_TRIALS trial_result · 2019-11-08Clinical Trial Update: A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder [Phase 4]
Phase 4 trial evaluating all-cause hospitalizations for Abilify MyCite users versus virtual matched controls in adults with schizophrenia, b…
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CLINICAL_TRIALS trial_result · 2019-11-05Clinical Trial Update: A Study of Staccato Loxapine (ADASUVE®) for Inhalation [Phase 3]
Phase 3 study update for Staccato Loxapine (ADASUVE) inhalation addressing psychomotor agitation and schizophrenia (potentially bipolar diso…
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CLINICAL_TRIALS trial_result · 2019-11-05Clinical Trial Update: Reducing Cardiovascular Risk in Adults With Serious Mental Illness [NA]
Clinical trial update on reducing cardiovascular risk in adults with serious mental illness; study completed with results posted in 2019.
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CLINICAL_TRIALS trial_result · 2019-11-04Clinical Trial Update: Open-Label Study of N-Acetylcysteine in Children and Adolescents 5-17 With Bipolar Spectrum Disorders [Phase 4]
Phase 4 open-label trial evaluating N-Acetylcysteine in children and adolescents (5-17) with bipolar spectrum disorders has completed; resul…
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FDA approval · 2019-10-29FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for lamotrigine submitted by Zydus Pharmaceuticals USA Inc. The exact changes covered by the supplem…
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FDA approval · 2019-10-29FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for lamotrigine from Zydus Pharmaceuticals USA Inc.
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FDA approval · 2019-10-22FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for ZYPREXA Intramuscular (olanzapine) from Eli Lilly. The approval relates to a supplemental su…
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FDA approval · 2019-10-22FDA Approved: ZYPREXA — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for ZYPREXA (olanzapine) submitted by Eli Lilly and Company, resulting in updated labeling to re…
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FDA label_change · 2019-10-22FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for ZYPREXA ZYDIS (olanzapine) submitted by Eli Lilly and Company, resulting in labeling changes…
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FDA approval · 2019-10-18FDA Approved: DIVALPROEX SODIUM — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' divalproex sodium as a generic product under Original Application (ANDA 209286).
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FDA approval · 2019-10-11FDA Approved: SECUADO — Original Application (Noven Therapeutics, LLC)
FDA approved SECUADO (asenapine) from Noven Therapeutics in an original NDA (212268) for treatment of schizophrenia and acute manic/mixed ep…
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CLINICAL_TRIALS trial_result · 2019-10-03Clinical Trial Update: Efficacy of Memantine add-on in the Treatment of Bipolar Disorder (Type I) Nonresponders or Partial Responders Patients [Phase 2]
Phase 2 clinical trial evaluating memantine add-on in bipolar disorder type I patients who are nonresponders or partial responders; current …
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CLINICAL_TRIALS trial_result · 2019-09-30Clinical Trial Update: Online Yoga for Individuals With Mood Disorders [NA]
A completed clinical trial assessing online yoga for individuals with mood disorders, including bipolar disorder and depression, with result…
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FDA approval · 2019-09-25FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental application for Lamictal (lamotrigine) submitted by GlaxoSmithKline LLC. The approval pertains to a suppleme…
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FDA label_change · 2019-09-25FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)
FDA approved a supplemental application for Lamictal ODT (lamotrigine) submitted by GlaxoSmithKline LLC, updating the product labeling.
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CLINICAL_TRIALS trial_result · 2019-09-16Clinical Trial Update: 12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017) [Phase 3]
Phase 3 trial evaluating the safety and efficacy of adding asenapine to ongoing lithium/valproate therapy in bipolar disorder; results have …
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CLINICAL_TRIALS trial_result · 2019-09-11Clinical Trial Update: Naturalistic Study, Comparison of Divalproex Extended Release (ER) and Quetiapine for Adults With Acute Mania or Mixed Episodes [Phase 4]
Phase 4 naturalistic trial comparing divalproex ER to quetiapine for adults with acute mania or mixed episodes in bipolar disorder; results …
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CLINICAL_TRIALS trial_result · 2019-09-06Clinical Trial Update: Ebselen as an add-on Treatment in Hypo/Mania [Phase 2]
Phase 2 clinical trial investigating ebselen as an add-on treatment in bipolar disorder with manic episodes; study completed.