Schizophrenia

• FDA approval · 2017-11-29
  FDA Approved: QUETIAPINE FUMARATE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approves Ingenus Pharmaceuticals' quetiapine fumarate under an Original Application, making a generic version of the antipsychotic avail…

• FDA approval · 2017-11-29
  FDA Approved: QUETIAPINE FUMARATE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for a generic quetiapine fumarate product from Aurobindo Pharma Limited. Quetiapine is used to treat s…

• FDA approval · 2017-11-29
  FDA Approved: QUETIAPINE EXTENDED RELEASE — Original Application (ACI Healthcare USA, Inc.)

  FDA approved an original application for quetiapine extended-release (generic) by ACI Healthcare USA, Inc., making a generic version of quet…

• FDA approval · 2017-11-17
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Clozapine submitted by Mylan Pharmaceuticals Inc. for the generic product (ANDA201824).

• FDA approval · 2017-10-17
  FDA Approved: FLUPHENAZINE DECANOATE — Original Application (Eugia US LLC)

  FDA approved an original ANDA for fluphenazine decanoate, a long-acting injectable antipsychotic.

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• FDA approval · 2017-09-26
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for quetiapine fumarate from Sun Pharmaceutical Industries, Inc., approving updates to the generic's…

• FDA approval · 2017-09-26
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application to market a generic quetiapine fumarate product from Aurobindo Pharma Limited.

• FDA approval · 2017-09-25
  FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)

  The FDA approved a supplemental application for LATUDA (lurasidone hydrochloride) from Sumitomo Pharma America, Inc., resulting in changes t…

• FDA approval · 2017-09-08
  FDA Approved: RISPERIDONE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s supplemental application for risperidone, approving a new generic risperidone product.

• FDA approval · 2017-08-11
  FDA Approved: INVEGA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved Janssen's supplemental application for INVEGA (paliperidone), expanding its approved indications.

• FDA approval · 2017-08-04
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for aripiprazole by Quallent Pharmaceuticals Health LLC, bringing a generic version of the antip…

• FDA approval · 2017-07-27
  FDA Approved: ABILIFY MAINTENA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved a supplemental application for ABILIFY MAINTENA (aripiprazole) submitted by Otsuka America Pharmaceutical, Inc.

• FDA approval · 2017-07-03
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for quetiapine fumarate filed by Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2017-06-30
  FDA Approved: QUETIAPINE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for quetiapine from Accord Healthcare Inc. (ANDA 202152).

• FDA approval · 2017-06-30
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for quetiapine fumarate (Quetiapine) by BluePoint Laboratories under an existing ANDA. This represen…

• FDA approval · 2017-06-30
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for a generic quetiapine fumarate by Alembic Pharmaceuticals Limited.

• FDA approval · 2017-06-30
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Macleods Pharmaceuticals Limited to market quetiapine fumarate. The approval covers a generic ve…

• FDA approval · 2017-06-22
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for quetiapine fumarate by Hikma Pharmaceuticals USA Inc., representing a new or updated approval fo…

• FDA approval · 2017-06-15
  FDA Approved: INVEGA SUSTENNA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for INVEGA SUSTENNA (paliperidone palmitate) submitted by Janssen Pharmaceuticals to modify or expan…

• FDA approval · 2017-06-05
  FDA Approved: ARISTADA — Supplemental Application (Alkermes, Inc.)

  The FDA is reviewing a supplemental application for ARISTADA (aripiprazole lauroxil) submitted by Alkermes, Inc. for potential changes or ad…

• FDA approval · 2017-05-17
  FDA Approved: QUETIAPINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' generic quetiapine (quetiapine) for the treatment of schizophrenia and bipolar disorder, expanding acces…

• FDA approval · 2017-05-12
  FDA Approved: HALOPERIDOL DECANOATE — Original Application (Sagent Pharmaceuticals)

  FDA approved haloperidol decanoate from Sagent Pharmaceuticals under the original application, a long-acting injectable antipsychotic.

• FDA approval · 2017-05-09
  FDA Approved: QUETIAPINE FUMARATE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's generic quetiapine fumarate under Original Application (ANDA090681) to bring a quetiapine fumarate product …

• FDA approval · 2017-04-25
  FDA Approved: CLOZAPINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for Clozapine from Aurobindo Pharma Limited, indicating approval of a supplemental submission for a …

• FDA approval · 2017-04-25
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Clozapine submitted by Mylan Pharmaceuticals Inc., granting updated marketing authorization for …