Schizophrenia

• FDA approval · 2025-01-13
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (VistaPharm, LLC)

  FDA approved a supplemental application for aripiprazole by VistaPharm, LLC (ANDA 212870). The authorization pertains to changes to the appr…

• FDA approval · 2025-01-13
  FDA Approved: LURASIDONE HYDROCHLORIDE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved Lurasidone hydrochloride from Torrent Pharmaceuticals Limited as an original generic drug application (ANDA 208055).

• FDA approval · 2024-12-20
  FDA Approved: FLUPHENAZINE DECANOATE — Supplemental Application (Mylan Institutional LLC)

  The FDA approved a supplemental application for Fluphenazine Decanoate submitted by Mylan Institutional LLC.

• EMA approval · 2024-12-18
  EMA Authorised: Zyprexa Velotab (olanzapine) — CHEPLAPHARM Registration GmbH

  The EMA authorised Zyprexa Velotab, a generic olanzapine product, under CHEPLAPHARM Registration GmbH for schizophrenia and bipolar disorder…

• FDA approval · 2024-12-12
  FDA Approved: CLOZAPINE — Original Application (Aurobindo Pharma Limited)

  The FDA approved the original application for CLOZAPINE by Aurobindo Pharma Limited, authorizing a generic Clozapine product.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2024-12-11
  FDA Approved: REXULTI — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

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

• FDA approval · 2024-12-10
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved an original application for chlorpromazine hydrochloride from Fresenius Kabi USA, LLC, making this generic antipsychotic av…

• FDA approval · 2024-12-03
  FDA Approved: LURASIDONE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for lurasidone hydrochloride from Amneal Pharmaceuticals LLC, supporting the generic product's conti…

• FDA approval · 2024-11-26
  FDA Approved: OLANZAPINE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Ascend Laboratories, LLC to market a generic olanzapine product under an ANDA. This marks the cl…

• FDA approval · 2024-11-18
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for Quetiapine fumarate by Macleods Pharmaceuticals Limited, enabling a generic version of the a…

• FDA approval · 2024-11-18
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved chlorpromazine hydrochloride as a generic product under an original ANDA for Camber Pharmaceuticals.

• FDA approval · 2024-11-12
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a generic form of aripiprazole from Aurobindo Pharma Limited.

• FDA approval · 2024-10-29
  FDA Approved: HALOPERIDOL — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for HALOPERIDOL LACTATE by Sagent Pharmaceuticals under anANDA, indicating an approved supplemental …

• FDA approval · 2024-10-04
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Piramal Critical Care Inc.)

  FDA approved a generic chlorpromazine hydrochloride product (Original Application) from Piramal Critical Care Inc.

• FDA approval · 2024-09-26
  FDA Approved: COBENFY — Original Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved COBENFY, a combination of xanomeline and trospium chloride, for the treatment of schizophrenia.

• FDA approval · 2024-09-26
  FDA Approved: PALIPERIDONE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved a generic version of paliperidone through an Original Application (ANDA) for Alembic Pharmaceuticals Limited.

• FDA approval · 2024-09-24
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Devatis, Inc.)

  The FDA approved Devatis, Inc.'s original application for chlorpromazine hydrochloride, a generic antipsychotic. It covers a generic product…

• FDA approval · 2024-09-12
  FDA Approved: CLOZARIL — Supplemental Application (HLS Therapeutics (USA), Inc.)

  The FDA approved a supplemental application for Clozaril (clozapine) submitted by HLS Therapeutics (USA), Inc., resulting in updated labelin…

• FDA approval · 2024-09-12
  FDA Approved: INVEGA HAFYERA — Supplemental Application (Janssen Pharmaceuticals, Inc)

  FDA approved a supplemental application for Invega Hafyera (paliperidone palmitate) from Janssen Pharmaceuticals, Inc., updating the product…

• FDA approval · 2024-09-09
  FDA Approved: RISPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for risperidone by Amneal Pharmaceuticals LLC to bring a generic version of the medication to market…

• FDA approval · 2024-08-21
  FDA Approved: LURASIDONE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for a generic Lurasidone hydrochloride product, authorizing a generic version of l…

• FDA approval · 2024-07-26
  FDA Approved: ERZOFRI EXTENDED-RELEASE — Original Application (Shandong Luye Pharmaceutical Co., Ltd.)

  The FDA approved a new extended-release product, ERZOFRI EXTENDED-RELEASE, containing paliperidone palmitate under an original NDA from Shan…

• FDA approval · 2024-07-23
  FDA Approved: FLUPHENAZINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's original application for fluphenazine hydrochloride as a generic drug.

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

  The EU authorised Byannli (paliperidone palmitate) for schizophrenia, as a long-acting injectable antipsychotic under Janssen-Cilag Internat…

• EMA approval · 2024-07-22
  EMA Authorised: Trevicta (previously Paliperidone Janssen) (paliperidone palmitate) — Janssen-Cilag International NV

  The European Medicines Agency authorised Trevicta, a brand-name long-acting paliperidone palmitate injection for schizophrenia, with Janssen…