Schizophrenia

• EMA approval · 2024-07-22
  EMA Authorised: Xeplion (paliperidone palmitate) — Janssen-Cilag International N.V.

  EMA authorised Xeplion (paliperidone palmitate) for schizophrenia, expanding options for long-acting injectable antipsychotics. Janssen-Cila…

• FDA approval · 2024-07-14
  FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for risperidone from Zydus Lifesciences Limited. This action authorizes a supplemental approval …

• EMA approval · 2024-07-12
  EMA Authorised: Invega (paliperidone) — Janssen-Cilag International NV

  The EMA authorised Invega (paliperidone) from Janssen-Cilag International NV for schizophrenia and related psychotic disorders. This marks i…

• FDA approval · 2024-07-08
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Clozapine submitted by Mylan Pharmaceuticals Inc. under the ANDA process.

• FDA approval · 2024-06-26
  FDA Approved: OLANZAPINE — Supplemental Application (American Regent, Inc.)

  FDA approved a supplemental application for olanzapine from American Regent, Inc. for the generic product; the notice indicates a supplement…

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• FDA approval · 2024-06-26
  FDA Approved: PALIPERIDONE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s original application for a generic paliperidone product.

• FDA approval · 2024-06-07
  FDA Approved: FLUPHENAZINE HYDROCHORIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings' generic fluphenazine hydrochloride via Original Application (ANDA), a generic antipsychotic used to tre…

• FDA approval · 2024-05-29
  FDA Approved: OLANZAPINE — Supplemental Application (Sandoz Inc)

  FDA approved Sandoz Inc.'s supplemental application for olanzapine (ANDA201588). This action updates the approval for the generic product, p…

• FDA approval · 2024-05-28
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  The FDA approved a supplemental application for aripiprazole submitted by Alembic Pharmaceuticals Inc., authorizing a modification to the pr…

• FDA approval · 2024-05-07
  FDA Approved: REXULTI — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved a supplemental application for Rexulti (brexpiprazole) by Otsuka America Pharmaceutical, Inc.

• FDA approval · 2024-05-06
  FDA Approved: PERPHENAZINE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approves an original application for a generic version of perphenazine by Macleods Pharmaceuticals Limited.

• FDA approval · 2024-04-11
  FDA Approved: HALOPERIDOL — Original Application (Lifestar Pharma LLC)

  FDA approved a generic haloperidol product from Lifestar Pharma LLC under an Original Application (ANDA 216918).

• FDA approval · 2024-04-02
  FDA Approved: FANAPT — Supplemental Application (Vanda Pharmaceuticals Inc.)

  The FDA approved a supplemental application for FANAPT (iloperidone) submitted by Vanda Pharmaceuticals Inc.

• FDA approval · 2024-03-21
  FDA Approved: PALIPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal's supplemental application for Paliperidone, enabling the marketing of a generic paliperidone product. This is an admini…

• FDA approval · 2024-03-15
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for aripiprazole submitted by Chartwell RX, LLC, indicating regulatory approval of a supplement rela…

• FDA approval · 2024-03-15
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for chlorpromazine hydrochloride (generic) from Zydus Lifesciences Limited.

• FDA approval · 2024-03-13
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved an original ANDA for chlorpromazine hydrochloride from Zydus Pharmaceuticals USA Inc., making this generic antipsychotic availa…

• FDA approval · 2024-03-12
  FDA Approved: OLANZAPINE — Supplemental Application (Aurobindo Pharma Limited)

  This FDA document relates to a supplemental application for the generic antipsychotic olanzapine from Aurobindo Pharma Limited. The action p…

• FDA approval · 2024-03-11
  FDA Approved: QUETIAPINE — Supplemental Application (Solco Healthcare U.S., LLC)

  FDA approved a supplemental application for a generic version of quetiapine, enabling Solco Healthcare U.S., LLC to market a generic quetiap…

• EMA approval · 2024-03-08
  EMA Authorised: Zalasta (olanzapine) — Krka

  Krka-licensed olanzapine (Zalasta) has been authorised in the EU for schizophrenia and bipolar disorder.

• FDA approval · 2024-03-05
  FDA Approved: RISPERIDONE — Supplemental Application (Solco Healthcare US, LLC)

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

• FDA approval · 2024-03-05
  FDA Approved: RISPERIDONE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for risperidone from Chartwell RX, LLC, authorizing the generic product under the approved label.

• FDA approval · 2023-12-05
  FDA Approved: RISPERIDONE — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva Pharmaceuticals' generic risperidone as an original application (ANDA214068).

• FDA approval · 2023-11-06
  FDA Approved: FLUPHENAZINE HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's generic fluphenazine hydrochloride under ANDA 216350.

• FDA approval · 2023-11-02
  FDA Approved: FLUPHENAZINE DECANOATE — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved the original application for fluphenazine decanoate, a long-acting antipsychotic, from Novadoz Pharmaceuticals LLC.