Bipolar Disorder

• FDA approval · 2023-04-19
  FDA Approved: QUETIAPINE — Supplemental Application (Solco Healthcare U.S., LLC)

  FDA approved a supplemental application for quetiapine from Solco Healthcare U.S., LLC to authorize a generic version of the drug for the U.…

• FDA approval · 2023-03-24
  FDA Approved: CARBAMAZEPINE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA's original ANDA for carbamazepine (generic anticonvulsant). This marks the availability of a generic carbamaz…

• FDA approval · 2023-03-22
  FDA Approved: OLANZAPINE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for a generic olanzapine product. The approval enables marketing of the olanzapine…

• FDA approval · 2023-03-02
  FDA Approved: CARBAMAZEPINE ER — Original Application (Epic Pharma, LLC)

  FDA approves the first original-application generic Carbamazepine ER from Epic Pharma, LLC under ANDA 216235. This extended-release formulat…

• FDA approval · 2023-02-24
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

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

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• FDA approval · 2023-02-24
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote ER (divalproex sodium) submitted by AbbVie, expanding the NDA with additional regul…

• FDA approval · 2023-02-24
  FDA Approved: OLANZAPINE — Original Application (Modavar Pharmaceuticals LLC)

  The FDA approved Modavar Pharmaceuticals LLC's original application for olanzapine, a generic antipsychotic. It is approved for the treatmen…

• FDA approval · 2023-02-10
  FDA Approved: OLANZAPINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for olanzapine from Dr. Reddy's Laboratories Limited (ANDA 076534), authorizing a generic olanzapine…

• FDA approval · 2023-01-31
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (VistaPharm, LLC)

  FDA approved a supplemental application for aripiprazole filed by VistaPharm, LLC, marking approval of a supplemental submission for this ge…

• FDA approval · 2023-01-25
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approves a supplemental application for divalproex sodium submitted by Ajanta Pharma USA Inc.

• FDA approval · 2023-01-13
  FDA Approved: RYKINDO EXTENDED-RELEASE MICROSPHERES — Original Application (Shandong Luye Pharmaceutical Co., Ltd.)

  FDA approved RYKINDO EXTENDED-RELEASE MICROSPHERES, an oral extended-release formulation of risperidone from Shandong Luye Pharmaceutical, u…

• FDA approval · 2023-01-05
  FDA Approved: LITHIUM CARBONATE LITHIUM CARBONATE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  The FDA approved a supplemental application for lithium carbonate from Alembic Pharmaceuticals Inc., signaling approval for an existing gene…

• FDA approval · 2022-12-27
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Aurobindo Pharma Limited)

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

• EMA approval · 2022-12-20
  EMA Authorised: Olanzapine Glenmark Europe (olanzapine) — Glenmark Arzneimittel GmbH

  Authorised olanzapine product (Glenmark Europe) for schizophrenia and bipolar disorder.

• EMA approval · 2022-12-20
  EMA Authorised: Olanzapine Glenmark (olanzapine) — Glenmark Arzneimittel GmbH

  Glenmark's olanzapine product has been authorised for schizophrenia and bipolar disorder in the EU.

• FDA approval · 2022-12-13
  FDA Approved: LURASIDONE HYDROCHLORIDE — Original Application (Ascend Laboratories, LLC)

  FDA approved lurasidone hydrochloride tablets as a generic Original Application for the treatment of schizophrenia and depressive episodes a…

• FDA approval · 2022-12-02
  FDA Approved: CARBAMAZEPINE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved the original application for a generic carbamazepine product from Ingenus Pharmaceuticals, LLC.

• FDA approval · 2022-11-21
  FDA Approved: EPITOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for EPITOL (carbamazepine) from Teva Pharmaceuticals USA, Inc. This action approves changes to the p…

• FDA approval · 2022-11-16
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for divalproex sodium, authorizing changes to the approved generic product unde…

• FDA approval · 2022-11-09
  FDA Approved: CARBAMAZEPINE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for carbamazepine filed by ANI Pharmaceuticals, Inc.

• FDA approval · 2022-11-08
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application for Carbamazepine submitted by Apotex Corp., a generic formulation.

• FDA approval · 2022-11-08
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for carbamazepine from Apotex Corp., approving changes to the approved generic product.

• FDA approval · 2022-10-27
  FDA Approved: ARIPIPRAZOLE — Original Application (Advagen Pharma Ltd)

  FDA approves Advagen Pharma Ltd's original application for a generic aripiprazole product.

• FDA approval · 2022-10-25
  FDA Approved: RISPERIDONE — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved a supplemental application for risperidone submitted by Solco Healthcare US, LLC.

• FDA approval · 2022-10-25
  FDA Approved: ARIPIPRAZOLE — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's original application for a generic aripiprazole product. Aripiprazole is used to treat schizophrenia, b…