Bipolar Disorder

• FDA approval · 2015-12-23
  FDA Approved: LAMOTRIGINE — Supplemental Application (Advagen Pharma Limited)

  FDA approved a supplemental application for lamotrigine by Advagen Pharma Limited, documenting the approved generic lamotrigine product unde…

• FDA approval · 2015-12-11
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Lamotrigine submitted by Zydus Pharmaceuticals USA Inc., authorizing changes to the product …

• FDA approval · 2015-11-30
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for divalproex sodium submitted by Zydus Pharmaceuticals USA Inc. The specific changes covered by th…

• FDA approval · 2015-11-30
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (BluePoint Laboratories)

  FDA approved BluePoint Laboratories' supplemental application for Divalproex Sodium under ANDA078239, granting approval of a generic product…

• FDA approval · 2015-11-27
  FDA Approved: OLANZAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for olanzapine from Macleods Pharmaceuticals Limited.

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• FDA approval · 2015-11-19
  FDA Approved: ZIPRASIDONE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for ziprasidone from Dr. Reddy's Laboratories Limited, approving a generic version under the AND…

• FDA approval · 2015-11-05
  FDA Approved: OLANZAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for the generic olanzapine product manufactured by Macleods Pharmaceuticals Limited under ANDA 20286…

• FDA approval · 2015-10-27
  FDA Approved: LAMOTRIGINE — Original Application (Endo USA, Inc.)

  FDA approved Endo USA, Inc.'s generic lamotrigine under ANDA204158, allowing the generic product to be marketed for the same indications as …

• FDA approval · 2015-10-22
  FDA Approved: RISPERIDONE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved a supplemental application for Risperidone from Jubilant Cadista Pharmaceuticals Inc., signifying an approval related to this g…

• FDA approval · 2015-10-20
  FDA Approved: OLANZAPINE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories, LLC's original application to manufacture and market a generic olanzapine product.

• FDA approval · 2015-10-05
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for the olanzapine and fluoxetine combination (Symbyax) submitted by Par Health USA, LLC.

• FDA approval · 2015-10-01
  FDA Tentative Approval: LAMOTRIGINE — Supplemental Application (NorthStar Rx LLC)

  FDA tentatively approved NorthStar Rx LLC's generic lamotrigine product under an ANDA.

• FDA approval · 2015-09-30
  FDA Approved: ARIPIPRAZOLE — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s Original Application for aripiprazole, granting approval of a generic version of the antipsychotic.

• FDA approval · 2015-09-23
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) from AbbVie, adding the sprinkle formulation to the produ…

• FDA approval · 2015-09-23
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2015-09-23
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for divalproex sodium from Aurobindo Pharma Limited.

• FDA approval · 2015-09-17
  FDA Approved: VRAYLAR — Original Application (Allergan, Inc.)

  The FDA approved VRAYLAR (cariprazine) under the original application NDA204370 for the treatment of schizophrenia and manic or mixed episod…

• FDA approval · 2015-09-04
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for quetiapine fumarate from Hikma Pharmaceuticals USA, indicating approval of changes to the pr…

• FDA approval · 2015-08-27
  FDA Approved: RISPERIDONE — Supplemental Application (Ajanta Pharma USA Inc.)

  The FDA approved a supplemental application for risperidone from Ajanta Pharma USA Inc., indicating an approved regulatory action for this p…

• FDA approval · 2015-08-21
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for quetiapine fumarate from Aurobindo Pharma Limited, providing a generic version of the antips…

• FDA approval · 2015-08-20
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Geodon (ziprasidone mesylate) submitted by Viatris Specialty LLC to update the approved product.

• FDA approval · 2015-08-20
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Geodon (ziprasidone) from Viatris Specialty LLC.

• FDA approval · 2015-08-14
  FDA Approved: ARIPIPRAZOLE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal's original ANDA for aripiprazole (ARIPIPRAZOLE), enabling the marketing of a generic version of this antipsychotic.

• FDA approval · 2015-08-12
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Saptalis Pharmaceuticals, LLC.)

  FDA approved a supplemental application for chlorpromazine hydrochloride from Saptalis Pharmaceuticals, LLC.

• FDA approval · 2015-07-27
  FDA Approved: LITHIUM CARBONATE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings, Inc.'s generic lithium carbonate under an original Abbreviated New Drug Application (ANDA) for use as a…