Schizophrenia

• FDA approval · 2023-11-01
  FDA Approved: UZEDY — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for UZEDY (risperidone) from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2023-11-01
  FDA Approved: ARIPIPRAZOLE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' generic oral aripiprazole under an original ANDA.

• FDA approval · 2023-10-24
  FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for ziprasidone hydrochloride from BluePoint Laboratories, granting ANDA-based approval of a gen…

• FDA approval · 2023-09-25
  FDA Approved: LYBALVI — Supplemental Application (Alkermes, Inc.)

  FDA approved a supplemental application for LYBALVI (olanzapine and samidorphan L-malate) from Alkermes. The action pertains to changes to t…

• FDA approval · 2023-09-21
  FDA Approved: PALIPERIDONE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for paliperidone filed by NorthStar RxLLC under ANDA205618.

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• FDA approval · 2023-09-19
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Accord Healthcare Inc.)

  FDA approves Accord Healthcare's supplemental application to market quetiapine fumarate as a generic drug.

• FDA approval · 2023-09-18
  FDA Approved: RISPERIDONE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved a supplemental application for risperidone by Jubilant Cadista Pharmaceuticals Inc., updating/expanding its approval for risper…

• FDA approval · 2023-09-11
  FDA Approved: FLUPHENAZINE HYDROCHLORIDE — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved an original Abbreviated New Drug Application for fluphenazine hydrochloride by Novadoz Pharmaceuticals LLC, adding a generic op…

• FDA approval · 2023-09-05
  FDA Approved: PALIPERIDONE — Supplemental Application (Tris Pharma Inc)

  FDA granted a supplemental approval for a generic paliperidone product from Tris Pharma Inc (ANDA 212807).

• FDA approval · 2023-08-23
  FDA Approved: PALIPERIDONE — Original Application (Camber Pharmaceuticals, Inc)

  FDA approved Camber Pharmaceuticals' generic paliperidone through original application, enabling a new generic option for this antipsychotic…

• FDA approval · 2023-08-18
  FDA Approved: FLUPHENAZINE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved the Original Application for Fluphenazine hydrochloride from Aurobindo Pharma Limited, granting approval of a generic antipsych…

• FDA approval · 2023-08-14
  FDA Approved: CLOZAPINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for clozapine from Aurobindo Pharma Limited, enabling the marketed generic product.

• FDA approval · 2023-08-08
  FDA Approved: RISPERIDONE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for risperidone from Aurobindo Pharma Limited, authorizing a generic risperidone product under ANDA …

• FDA approval · 2023-08-08
  FDA Approved: ZIPRASIDONE MESYLATE — Supplemental Application (Fosun Pharma USA Inc.)

  FDA approved a supplemental application for ziprasidone mesylate, a salt form of ziprasidone, submitted by Fosun Pharma USA Inc.

• FDA approval · 2023-07-21
  FDA Approved: LURASIDONE HYDROCHLORIDE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental ANDA for Lurasidone hydrochloride from Zydus Pharmaceuticals USA Inc., enabling the marketing of a generic versi…

• FDA approval · 2023-07-17
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for aripiprazole from Ascend Laboratories, allowing a generic version to be marketed.

• FDA approval · 2023-06-29
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's supplemental application for ARIPIPRAZOLE, granting approval of the generic ARIPIPRAZOLE product.

• FDA approval · 2023-06-15
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for aripiprazole from Quallent Pharmaceuticals Health LLC.

• FDA approval · 2023-06-12
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for ARIPIPRAZOLE submitted by Unichem Pharmaceuticals (USA), Inc., enabling the generic product to b…

• FDA approval · 2023-06-09
  FDA Approved: LURASIDONE HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approves a generic Lurasidone hydrochloride tablet (ANDA 212124) from Macleods Pharmaceuticals Limited. The product is indicated for sch…

• FDA approval · 2023-06-07
  FDA Approved: OLANZAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approves a supplemental application for olanzapine from Macleods Pharmaceuticals Limited, granting approval of a generic version of the …

• FDA approval · 2023-06-07
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Quetiapine Fumarate by Macleods Pharmaceuticals Limited under ANDA203359.

• FDA approval · 2023-06-07
  FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for ziprasidone hydrochloride filed by Macleods Pharmaceuticals Limited under an ANDA, indicating a …

• FDA approval · 2023-06-07
  FDA Approved: OLANZAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Olanzapine submitted by Macleods Pharmaceuticals Limited (ANDA 203044). This is a regulatory upd…

• FDA approval · 2023-06-07
  FDA Approved: QUETIAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for a generic quetiapine product from Macleods Pharmaceuticals Limited.