Bipolar Disorder

• FDA approval · 2025-10-07
  FDA Approved: LAMOTRIGINE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' generic lamotrigine as an original application, authorizing the first generic version of lamotri…

• FDA approval · 2025-09-30
  FDA Approved: TEGRETOL XR — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol XR (carbamazepine) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2025-09-29
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Lamotrigine from Zydus Pharmaceuticals USA Inc., resulting in clearance for a generic lamotrigin…

• FDA approval · 2025-09-17
  FDA Approved: ZIPRASIDONE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for ziprasidone from Dr. Reddy's Laboratories Limited, indicating regulatory action on an existi…

• FDA approval · 2025-09-17
  FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Ziprasidone hydrochloride submitted by Apotex Corp., for an already approved generic product. Th…

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• FDA approval · 2025-09-16
  FDA Approved: SUBVENITE — Original Application (OWP Pharmaceuticals, Inc.)

  The FDA approved SUBVENITE (lamotrigine) through an Original Application filed by OWP Pharmaceuticals, Inc.

• FDA approval · 2025-09-12
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA granted a supplemental approval for a generic quetiapine fumarate product from Hikma Pharmaceuticals USA Inc. (ANDA 090749). The approva…

• FDA approval · 2025-09-04
  FDA Approved: PALIPERIDONE — Original Application (Eskayef Pharmaceuticals Limited)

  FDA approved Eskayef Pharmaceuticals Limited's original application for paliperidone (generic paliperidone). The approval makes a generic ve…

• FDA approval · 2025-09-03
  FDA Approved: ZIPRASIDONE MESYLATE — Original Application (STERISCIENCE SPECIALTIES PRIVATE LIMITED)

  FDA approved an original application for ziprasidone mesylate from SterisScience Specialties Private Limited, enabling a generic version of …

• FDA approval · 2025-09-02
  FDA Approved: RISPERIDONE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' generic risperidone through an Original Application for use in established indications.

• FDA approval · 2025-09-02
  FDA Approved: RISPERIDONE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approval of a generic risperidone original application by Amneal Pharmaceuticals LLC.

• FDA approval · 2025-08-15
  FDA Approved: CARBAMAZEPINE ER — Supplemental Application (Bostal LLC)

  FDA approved a supplemental application for Carbamazepine ER submitted by Bostal LLC.

• FDA approval · 2025-08-15
  FDA Approved: LAMOTRIGINE — Supplemental Application (Ajanta Pharma USA Inc.)

  The FDA approved a supplemental application for lamotrigine from Ajanta Pharma USA Inc. under an ANDA.

• FDA approval · 2025-08-12
  FDA Approved: DIVALPROEX SODIUM — Original Application (First Nation Group, LLC)

  FDA approved the original ANDA for divalproex sodium from First Nation Group, LLC, authorizing a generic product to be marketed for the same…

• FDA approval · 2025-08-06
  FDA Approved: LAMOTRIGINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for Lamotrigine from Unichem Pharmaceuticals (USA), Inc., relating to the generic lamotrigine pr…

• FDA approval · 2025-07-30
  FDA Approved: LOXAPINE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for LOXAPINE by Actavis Pharma, Inc. under ANDA072206, indicating an updated indication or label for…

• FDA approval · 2025-07-23
  FDA Approved: LURASIDONE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' supplemental ANDA for Lurasidone hydrochloride, enabling a generic version to be marketed in the U.S. L…

• FDA approval · 2025-07-08
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for quetiapine fumarate from Aurobindo Pharma Limited to market the generic product for the same ind…

• FDA approval · 2025-07-01
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Bionpharma Inc.,)

  FDA approved a supplemental application for carbamazepine from Bionpharma Inc. This action confirms regulatory clearance for the product und…

• FDA approval · 2025-07-01
  FDA Approved: LURASIDONE HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Lurasidone Hydrochloride from Macleods Pharmaceuticals Limited, authorizing the generic product.…

• FDA approval · 2025-06-11
  FDA Approved: OLANZAPINE INTRAMUSCULAR — Original Application (UBI Pharma Inc.)

  The FDA approved the intramuscular olanzapine generic from UBI Pharma Inc. under an Original Application, for use in agitation associated wi…

• FDA approval · 2025-05-27
  FDA Approved: ASENAPINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for asenapine submitted by Alembic Pharmaceuticals Limited.

• FDA approval · 2025-05-16
  FDA Approved: RISPERIDONE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals, LLC's supplemental application for risperidone under an ANDA.

• FDA approval · 2025-05-16
  FDA Approved: OLANZAPINE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s original generic application for olanzapine, establishing a generic version of the antipsychot…

• EMA approval · 2025-05-12
  EMA Authorised: Olanzapine Teva (olanzapine) — Teva B.V.

  The EMA authorised Teva B.V. to market Olanzapine for schizophrenia and bipolar disorder in the European Union.