Bipolar Disorder

• FDA approval · 2014-10-28
  FDA Approved: QUETIAPINE FUMARATE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's original generic application for quetiapine fumarate, a second-generation antipsychotic used …

• FDA approval · 2014-10-21
  FDA Approved: SAPHRIS — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for SAPHRIS (asenapine maleate) from Allergan, Inc.

• FDA approval · 2014-09-30
  FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ZYPREXA INTRAMUSCULAR (olanzapine) by Eli Lilly and Company. The action results in changes t…

• FDA approval · 2014-09-26
  FDA Approved: RISPERIDONE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's supplemental application for risperidone (generic), enabling the marketed generic version to …

• FDA approval · 2014-09-26
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for lamotrigine from Zydus Pharmaceuticals USA Inc., resulting in updated labeling for the gener…

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• FDA approval · 2014-09-25
  FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for risperidone from Zydus Lifesciences Limited.

• FDA approval · 2014-09-25
  FDA Approved: RISPERIDONE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved a supplemental application for risperidone by Westminster Pharmaceuticals, LLC to support a generic version of risperidone.

• FDA approval · 2014-09-19
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (BluePoint Laboratories)

  FDA approves a supplemental application for Divalproex Sodium by BluePoint Laboratories, indicating clearance of a supplemental filing for a…

• FDA approval · 2014-09-16
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Tegretol (carbamazepine) submitted by Novartis Pharmaceuticals Corporation. The action updat…

• FDA approval · 2014-09-16
  FDA Approved: TEGRETOL XR — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol XR (carbamazepine) from Novartis Pharmaceuticals Corporation, resulting in updated labe…

• FDA approval · 2014-08-15
  FDA Approved: OLANZAPINE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved Macleods Pharmaceuticals Limited's generic olanzapine under an Original Application (ANDA).

• FDA approval · 2014-08-11
  FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ZYPREXA INTRAMUSCULAR (olanzapine) submitted by Eli Lilly and Company.

• FDA approval · 2014-08-05
  FDA Approved: VALPROIC ACID — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for Valproic acid submitted by Upsher-Smith Laboratories, LLC.

• FDA approval · 2014-06-19
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  The FDA granted a supplemental approval for Depakote Sprinkles (divalproex sodium) from AbbVie under a supplemental application.

• FDA approval · 2014-06-19
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote (divalproex sodium) submitted by AbbVie Inc. The approval indicates the agency has appr…

• FDA approval · 2014-06-12
  FDA Approved: LAMOTRIGINE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals' lamotrigine chewable dispersible as a generic lamotrigine product under an original ANDA.

• FDA approval · 2014-06-10
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA supplemental approval for Lamictal (lamotrigine) submitted by GlaxoSmithKline LLC, leading to updated labeling.

• FDA approval · 2014-06-10
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL ODT (lamotrigine) from GlaxoSmithKline LLC.

• FDA approval · 2014-06-10
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL XR (lamotrigine) submitted by GlaxoSmithKline LLC.

• FDA approval · 2014-06-09
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) submitted by AbbVie. The action involves Depakote Sprinkl…

• FDA approval · 2014-06-09
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2014-06-02
  FDA Approved: DIVALPROEX SODIUM — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original ANDA for divalproex sodium, enabling a generic version of the drug.

• FDA approval · 2014-05-15
  FDA Approved: OLANZAPINE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for a generic olanzapine manufactured by Aurobindo Pharma Limited.

• FDA approval · 2014-04-28
  FDA Approved: RISPERDAL — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal (risperidone) from Janssen Pharmaceuticals, Inc. The approval updates the drug's label…

• FDA approval · 2014-04-24
  FDA Approved: LAMOTRIGINE EXTENDED RELEASE — Supplemental Application (Par Health USA, LLC)

  FDA approves a supplemental abbreviated new drug application for Lamotrigine Extended Release from Par Health USA, LLC.