Bipolar Disorder

• CLINICAL_TRIALS trial_result · 2014-12-23
  Clinical Trial Update: Functional and Neurochemical Brain Changes Bipolar Depression

  The clinical trial examining functional and neurochemical brain changes in bipolar depression has completed.

• FDA approval · 2014-12-20
  FDA Approved: OLANZAPINE — Supplemental Application (Dr. Reddy's Laboratories Ltd.)

  FDA approved Dr. Reddy's Laboratories Ltd.'s supplemental application for olanzapine, enabling a generic olanzapine product.

• FDA approval · 2014-12-19
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for a generic olanzapine and fluoxetine fixed-dose product, expanding access to the olanzapine/…

• FDA approval · 2014-12-19
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's supplemental application for a generic fixed-dose combination of olanzapine and fluoxetine (olanzapine and fluoxetine).

• CLINICAL_TRIALS trial_result · 2014-12-17
  Clinical Trial Update: Study in Adolescents With Schizophrenia or Bipolar Disorder [Phase 4]

  Phase 4 clinical trial in adolescents with schizophrenia or Bipolar I Disorder has completed and results were posted in 2014.

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• CLINICAL_TRIALS trial_result · 2014-12-17
  Clinical Trial Update: Aripiprazole in Late Life Bipolar Disorder [Phase 4]

  An update noting completion of a Phase 4 clinical trial evaluating aripiprazole for bipolar disorder in older adults.

• FDA approval · 2014-12-13
  FDA Approved: LAMOTRIGINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Lamotrigine by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2014-12-12
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for lamotrigine from Aurobindo Pharma Limited, reflecting changes to labeling for this generic produ…

• FDA approval · 2014-12-12
  FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for lamotrigine from Alembic Pharmaceuticals Limited under an ANDA. This confirms approval of a supp…

• FDA approval · 2014-12-10
  FDA Approved: LAMOTRIGINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA granted a supplemental approval for Lamotrigine from Unichem Pharmaceuticals (USA), Inc. under an ANDA supplemental application. The sni…

• FDA approval · 2014-12-10
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  The FDA approved Viatris Specialty LLC's supplemental application for Geodon (ziprasidone mesylate).

• FDA approval · 2014-12-10
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  FDA approved a supplemental application to authorize a Lamotrigine Kit from OWP Pharmaceuticals, Inc., expanding the approved lamotrigine pr…

• FDA approval · 2014-12-10
  FDA Approved: LAMOTRIGINE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved a supplemental application for lamotrigine from Jubilant Cadista Pharmaceuticals Inc. This marks an approval of a generic lamot…

• FDA approval · 2014-12-08
  FDA Approved: OLANZAPINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a generic olanzapine product from Aurobindo Pharma Limited.

• FDA approval · 2014-12-08
  FDA Approved: OLANZAPINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for olanzapine submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2014-12-08
  FDA Approved: OLANZAPINE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approves Jubilant Cadista Pharmaceuticals Inc.'s supplemental application for olanzapine, enabling a generic olanzapine product.

• FDA approval · 2014-12-05
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for lamotrigine by Aurobindo Pharma Limited, authorizing changes to an existing lamotrigine product.

• CLINICAL_TRIALS trial_result · 2014-12-03
  Clinical Trial Update: Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling [Phase 3]

  A Phase 3 clinical trial update indicates completion of a combination therapy study aimed at treating bipolar disorder with rapid cycling. T…

• FDA approval · 2014-11-28
  FDA Approved: RISPERIDONE — Supplemental Application (Natco Pharma USA LLC)

  The FDA approved a supplemental application for risperidone from Natco Pharma USA LLC under an ANDA, enabling continued marketing of a gener…

• CLINICAL_TRIALS withdrawal · 2014-11-21
  Clinical Trial Update: Paliperidone Palmitate Efficacy and Safety in Bipolar Disorder Complicated by Alcoholism [Phase 4]

  Phase 4 trial of paliperidone palmitate for bipolar disorder complicated by alcoholism has been withdrawn.

• FDA approval · 2014-11-20
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) submitted by AbbVie Inc.

• FDA approval · 2014-11-20
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Dr. Reddy's Laboratories Ltd)

  FDA approved a supplemental application for divalproex sodium from Dr. Reddy's Laboratories Ltd.

• FDA approval · 2014-11-20
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for DEPAKOTE ER (divalproex sodium) submitted by AbbVie Inc.

• CLINICAL_TRIALS trial_result · 2014-11-20
  Clinical Trial Update: Self-Management Addressing Heart Disease Risk Trial [Phase 3]

  Phase 3 trial evaluating a self-management program to reduce heart disease risk in people with bipolar disorder; results have been posted.

• FDA approval · 2014-11-18
  FDA Approved: SAPHRIS — Supplemental Application (Allergan, Inc.)

  The FDA approved Allergan's supplemental application for SAPHRIS (asenapine) to update its labeling, reflecting an expanded or clarified ind…