Bipolar Disorder

• EMA approval · 2026-08-21
  EMA Authorised: Aripiprazole Sandoz (aripiprazole) — Sandoz GmbH

  Authorised new aripiprazole product (Sandoz) for schizophrenia and bipolar disorder.

• EMA approval · 2026-07-10
  EMA Authorised: Olazax (olanzapine) — Glenmark Pharmaceuticals s.r.o.

  Olazax, containing olanzapine, has been authorised for schizophrenia and bipolar disorder in the EU.

• FDA approval · 2026-04-22
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for quetiapine fumarate from Accord Healthcare Inc., updating the product's labeling and/or indicati…

• FDA approval · 2026-04-13
  FDA Approved: LURASIDONE HYDROCHLORIDE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approves Torrent Pharmaceuticals Limited's supplemental application for lurasidone hydrochloride, signifying an update to the product's …

• FDA approval · 2026-04-13
  FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for Lamotrigine from Alembic Pharmaceuticals Limited under ANDA 090607.

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• EMA approval · 2026-04-13
  EMA Authorised: Aripiprazole Sandoz (aripiprazole) — Sandoz GmbH

  The European Medicines Agency authorised Aripiprazole Sandoz (aripiprazole) by Sandoz GmbH for treating schizophrenia and bipolar disorder.

• FDA approval · 2026-04-10
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lamotrigine Kit, a generic lamotrigine product by OWP Pharmaceuticals, Inc.

• FDA approval · 2026-04-09
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Lamotrigine submitted by Aurobindo Pharma Limited.

• FDA approval · 2026-04-09
  FDA Approved: LAMOTRIGINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for a generic lamotrigine product from Unichem Pharmaceuticals (USA), Inc.

• EMA approval · 2026-04-08
  EMA Authorised: Aripiprazole Zentiva (aripiprazole) — Zentiva, k.s.

  The EMA has authorised Aripiprazole Zentiva (aripiprazole) for the treatment of schizophrenia and bipolar disorder. The marketing authorizat…

• FDA approval · 2026-04-08
  FDA Approved: VALPROIC ACID — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Valproic Acid from Bionpharma Inc., for a generic product under ANDA 073484. This action confirm…

• FDA approval · 2026-04-01
  FDA Approved: LAMOTRIGINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA approval · 2026-03-31
  FDA Approved: VALPROIC ACID — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for valproic acid submitted by ANI Pharmaceuticals, Inc. The approval covers changes to the product …

• FDA approval · 2026-03-31
  FDA Approved: VALPROIC ACID — Supplemental Application (Xttrium Laboratories Inc.)

  FDA approved a supplemental application for VALPROIC ACID from Xttrium Laboratories Inc. The approval concerns changes to the generic produc…

• FDA approval · 2026-03-27
  FDA Approved: ASENAPINE — Supplemental Application (Sigmapharm Laboratories, LLC)

  FDA approved a supplemental application for asenapine from Sigmapharm Laboratories, allowing a generic version of asenapine to be marketed. …

• FDA approval · 2026-03-20
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's supplemental application for carbamazepine, reflecting an update to the product's labeling un…

• FDA approval · 2026-03-20
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for carbamazepine from Alembic Pharmaceuticals, enabling changes to the product's labeling.

• FDA approval · 2026-03-06
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for carbamazepine from Apotex Corp., granting approval for the generic product under ANDA075948. The…

• FDA approval · 2026-03-05
  FDA Approved: OLANZAPINE — Original Application (GLENMARK PHARMACEUTICALS INC., USA)

  FDA approved Glenmark's original application for a generic olanzapine product.

• EMA approval · 2026-02-27
  EMA Authorised: Zyprexa (olanzapine) — CHEPLAPHARM Registration GmbH

  The EMA authorised Zyprexa (olanzapine) for schizophrenia and bipolar disorder under CHEPLAPHARM Registration GmbH as the marketing authoris…

• EMA approval · 2026-02-25
  EMA Authorised: Sycrest (asenapine maleate) — Organon N.V.

  The EMA authorised Sycrest (asenapine maleate) for the treatment of bipolar disorder. Organon N.V. is the marketing authorisation holder.

• FDA approval · 2026-02-25
  FDA Approved: LAMOTRIGINE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals' original ANDA for generic lamotrigine.

• FDA approval · 2026-02-18
  FDA Approved: ARIPIPRAZOLE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original ANDA for aripiprazole from Aurobindo Pharma Limited, providing a generic version of the antipsychotic. The approva…

• FDA approval · 2026-02-09
  FDA Approved: OLANZAPINE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for olanzapine from Dr. Reddy's Laboratories Inc., updating the existing approval for this product.

• FDA approval · 2026-02-09
  FDA Approved: OLANZAPINE — Supplemental Application (Dr. Reddy's Laboratories Ltd.)

  FDA approved Dr. Reddy's Laboratories' supplemental application for olanzapine, confirming the approval of a generic olanzapine product.