Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2010-01-27FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a Supplemental Application for carbamazepine by Sun Pharmaceutical Industries, Inc. under an ANDA, marking an approved change t…
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CLINICAL_TRIALS trial_result · 2010-01-22Clinical Trial Update: 3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects [Phase 3]
Phase 3 trial evaluating ziprasidone with lithium or divalproex for acutely manic bipolar disorder has completed with results posted in 2010…
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FDA approval · 2010-01-21FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)
FDA approved a supplemental application for Lamotrigine Kit submitted by OWP Pharmaceuticals, Inc.
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FDA approval · 2010-01-20FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Upsher-Smith Laboratories, LLC)
The FDA approved a supplemental application for divalproex sodium submitted by Upsher-Smith Laboratories, LLC.
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FDA approval · 2010-01-20FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for divalproex sodium. The approval covers the submitted supplemental chang…
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FDA approval · 2010-01-20FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Bionpharma Inc.)
FDA approves a supplemental application for divalproex sodium filed by Bionpharma Inc., resulting in an approved update under the ANDA proce…
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CLINICAL_TRIALS trial_result · 2010-01-15Clinical Trial Update: Efficacy and Safety of Utapine vs. Seroquel in Patients With Bipolar Mania [Phase 4]
Phase 4 trial update comparing the efficacy and safety of Utapine versus Seroquel in patients with bipolar mania.
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FDA approval · 2010-01-12FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)
The FDA approved a supplemental application for risperidone filed by Zydus Lifesciences Limited, granting approval for a generic version und…
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FDA approval · 2010-01-12FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for divalproex sodium submitted by Sun Pharmaceutical Industries, Inc.
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CLINICAL_TRIALS safety_alert · 2010-01-12Clinical Trial Update: Heart Rate Changes in Schizophrenic and Bipolar Patients Under the Medication of Aripiprazole and Quetiapine [Phase 4]
A Phase 4 clinical trial update reports heart rate changes in patients with schizophrenia or bipolar disorder treated with aripiprazole or q…
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FDA approval · 2010-01-07FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for divalproex sodium submitted by Zydus Pharmaceuticals USA Inc.
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CLINICAL_TRIALS trial_result · 2010-01-07Clinical Trial Update: Proof Of Mechanism Study To Determine Efficacy Of PF-04455242 In Blocking Spiradoline (PF-00345768) Stimulated Prolactin Release [Phase 1]
Pfizer completed a Phase 1 proof-of-mechanism study to determine if PF-04455242 can block spiradoline-stimulated prolactin release in bipola…
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FDA approval · 2010-01-06FDA Approved: VALPROIC ACID — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for valproic acid submitted by ANI Pharmaceuticals, Inc.
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FDA approval · 2010-01-06FDA Approved: VALPROIC ACID — Supplemental Application (Xttrium Laboratories Inc.)
FDA approved a supplemental application for valproic acid from Xttrium Laboratories Inc., granting approval of a generic product.
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FDA approval · 2009-12-15FDA Approved: CARBAMAZEPINE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for Carbamazepine (generic) submitted by Chartwell RX, LLC.
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FDA approval · 2009-12-15FDA Approved: RISPERIDONE — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for risperidone from ANI Pharmaceuticals, Inc., resulting in a generic risperidone product being…
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CLINICAL_TRIALS trial_result · 2009-12-14Clinical Trial Update: Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed) [Phase 3]
Phase 3 clinical trial assessing safety and maintenance of effect of ziprasidone plus a mood stabilizer in bipolar I disorder (manic or mixe…
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FDA approval · 2009-12-09FDA Approved: HALOPERIDOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for HALOPERIDOL LACTATE from Hikma Pharmaceuticals USA Inc., authorizing modifications under the AND…
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FDA approval · 2009-12-04FDA Approved: ZYPREXA — Supplemental Application (Eli Lilly and Company)
FDA approved a supplemental application for ZYPREXA (olanzapine) filed by Eli Lilly and Company, expanding the regulatory scope of the produ…
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FDA label_change · 2009-12-02FDA Approved: SEROQUEL — Supplemental Application (H2-Pharma, LLC)
The FDA approved a supplemental application for SEROQUEL (quetiapine) submitted by H2-Pharma, LLC, likely involving changes to the drug's la…
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FDA approval · 2009-12-02FDA Approved: RISPERIDONE — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approves a supplemental application for a generic risperidone version manufactured by Torrent Pharmaceuticals Limited.
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FDA approval · 2009-11-25FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for Carbamazepine from Apotex Corp.
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FDA approval · 2009-11-20FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Geodon (ziprasidone) submitted by Viatris Specialty LLC.
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FDA approval · 2009-11-18FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for Carbamazepine by Torrent Pharmaceuticals Limited to update labeling.
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FDA approval · 2009-11-12FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for GEODON (ziprasidone) from Viatris Specialty LLC, updating the product’s labeling.