Bipolar Disorder

• FDA approval · 2021-05-28
  FDA Approved: LYBALVI — Original Application (Alkermes, Inc.)

  FDA approved LYBALVI (olanzapine and samidorphan L-malate) from Alkermes as an original drug application. It is indicated for the treatment …

• FDA approval · 2021-05-18
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Geodon (ziprasidone mesylate) filed by Viatris Specialty LLC.

• FDA approval · 2021-05-18
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2021-05-13
  FDA Approved: LURASIDONE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals' generic Lurasidone hydrochloride tablets under an Original Application (ANDA213248). Lurasidone is use…

• FDA approval · 2021-04-23
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Aurobindo Pharma Limited)

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

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• FDA approval · 2021-04-13
  FDA Approved: CARBAMAZEPINE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith Laboratories' Original Application for carbamazepine (generic) under ANDA213311.

• FDA approval · 2021-03-31
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for LAMICTAL ODT (lamotrigine) submitted by GlaxoSmithKline, updating its regulatory status for …

• FDA approval · 2021-03-10
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Lamotrigine from Zydus Pharmaceuticals USA Inc., indicating an update to its labeling/indica…

• FDA approval · 2021-03-09
  FDA Approved: ASENAPINE — Original Application (Breckenridge Pharmaceutical, Inc.)

  FDA approved a generic version of asenapine (asenapine maleate) from Breckenridge Pharmaceutical, Inc. via an Original Application (ANDA2059…

• FDA approval · 2021-02-26
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for the generic olanzapine/fluoxetine combination, expanding access to this treatment.

• FDA approval · 2021-02-26
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for a generic olanzapine and fluoxetine product. The combination is indicated for depressive ep…

• FDA approval · 2021-02-12
  FDA Approved: RISPERIDONE — Supplemental Application (Janssen Pharmaceutical, Inc.)

  The FDA approved Janssen's supplemental application for risperidone, resulting in changes to its labeling/indications.

• FDA approval · 2021-02-10
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2021-02-04
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for a generic fixed-dose combination of olanzapine and fluoxetine from Par Health USA, LLC. The …

• FDA approval · 2021-02-01
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for ARIPIPRAZOLE from Alembic Pharmaceuticals Inc., authorizing a generic aripiprazole product. The …

• FDA approval · 2021-02-01
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Inc)

  FDA approves Dr. Reddy's Laboratories' supplemental application to add a generic aripiprazole orally disintegrating tablet.

• FDA approval · 2021-01-22
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Lannett Company, Inc.)

  FDA approved Lannett's generic chlorpromazine hydrochloride (ANDA 212996), authorizing the marketing of a generic chlorpromazine hydrochlori…

• FDA approval · 2021-01-19
  FDA Approved: LAMOTRIGINE — Original Application (Ajanta Pharma USA Inc.)

  FDA approves Ajanta Pharma USA Inc.'s original ANDA for lamotrigine, authorizing sale of a generic lamotrigine product for the same indicati…

• FDA approval · 2020-12-31
  FDA Approved: OLANZAPINE — Original Application (Hisun Pharmaceuticals USA, Inc.)

  FDA approved a generic olanzapine product under Hisun Pharmaceuticals USA, Inc.'s Original Application for olanzapine.

• FDA approval · 2020-12-31
  FDA Approved: OLANZAPINE — Original Application (Hisun Pharmaceuticals USA, Inc.)

  FDA approved the original abbreviated new drug application for olanzapine, a generic form manufactured by Hisun Pharmaceuticals USA, for use…

• FDA approval · 2020-12-10
  FDA Approved: ASENAPINE — Original Application (Alembic Pharmaceuticals Limited)

  The FDA approved Alembic Pharmaceuticals Limited's original ANDA for asenapine, enabling a generic version of the drug to be marketed.

• FDA approval · 2020-12-10
  FDA Approved: ASENAPINE — Original Application (Sigmapharm Laboratories, LLC)

  FDA approved Sigmapharm Laboratories, LLC's original (ANDA) application for asenapine, enabling a generic version to enter the market. The a…

• FDA approval · 2020-12-10
  FDA Approved: ASENAPINE — Original Application (Breckenridge Pharmaceutical, Inc.)

  FDA approved Breckenridge Pharmaceutical's original application for a generic asenapine maleate product. The generic is intended for the sam…

• FDA approval · 2020-11-17
  FDA Approved: RISPERIDONE — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved Solco Healthcare US, LLC's supplemental application to market a generic risperidone product.

• FDA approval · 2020-11-16
  FDA Approved: OLANZAPINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Teva Pharmaceuticals' olanzapine product under an ANDA.