Schizophrenia

• FDA approval · 2013-08-13
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Geodon (ziprasidone) submitted by Viatris Specialty LLC.

• FDA approval · 2013-07-30
  FDA Approved: ABILIFY — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved a supplemental application for Abilify (aripiprazole) by Otsuka America Pharmaceutical, Inc. The action results in updated labe…

• FDA approval · 2013-07-25
  FDA Approved: ZIPRASIDONE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited's supplemental application for ziprasidone under an ANDA, indicating an approved change to the…

• FDA approval · 2013-07-19
  FDA Approved: FANAPT — Supplemental Application (Vanda Pharmaceuticals Inc.)

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

• FDA approval · 2013-07-12
  FDA Approved: FANAPT — Supplemental Application (Vanda Pharmaceuticals Inc.)

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

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• FDA approval · 2013-07-12
  FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)

  FDA approved a supplemental application for LATUDA (lurasidone hydrochloride) filed by Sumitomo Pharma America, Inc.

• FDA approval · 2013-07-03
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Geodon (ziprasidone mesylate) submitted by Viatris Specialty LLC.

• FDA approval · 2013-07-03
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA approved Viatris Specialty LLC's supplemental application for Geodon (ziprasidone).

• FDA approval · 2013-06-28
  FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)

  FDA approved a supplemental application for LATUDA (lurasidone hydrochloride) submitted by Sumitomo Pharma America, Inc.

• FDA approval · 2013-06-13
  FDA Approved: RISPERDAL — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for RISPERDAL (risperidone) from Janssen Pharmaceuticals, Inc.

• FDA approval · 2013-06-05
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Patriot Pharmaceuticals LLC)

  The FDA approved a supplemental application for HALOPERIDOL DECANOATE from Patriot Pharmaceuticals LLC.

• FDA approval · 2013-05-30
  FDA Approved: FANAPT — Supplemental Application (Vanda Pharmaceuticals Inc.)

  FDA approved a supplemental application for FANAPT (iloperidone) from Vanda Pharmaceuticals Inc. This approval pertains to a supplement to t…

• FDA approval · 2013-05-20
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Clozapine from Mylan Pharmaceuticals Inc., indicating approval of a generic Clozapine product. C…

• FDA approval · 2013-05-06
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Patriot Pharmaceuticals LLC)

  FDA approved a supplemental application for haloperidol decanoate, a long-acting injectable antipsychotic, from Patriot Pharmaceuticals LLC.

• FDA approval · 2013-04-30
  FDA Approved: SEROQUEL — Supplemental Application (H2-Pharma, LLC)

  The FDA approved a supplemental NDA for SEROQUEL (quetiapine) filed by H2-Pharma, LLC.

• FDA approval · 2013-04-30
  FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for SEROQUEL XR (quetiapine) submitted by AstraZeneca, resulting in changes to the product label…

• FDA approval · 2013-03-27
  FDA Approved: ZYPREXA RELPREVV — Supplemental Application (H2-Pharma LLC)

  The FDA approved a supplemental application for ZYPREXA RELPREVV (olanzapine pamoate) submitted by H2-Pharma LLC.

• FDA approval · 2013-03-22
  FDA Approved: RISPERIDONE — Supplemental Application (Natco Pharma USA LLC)

  FDA approved a supplemental application for risperidone from Natco Pharma USA LLC under an ANDA.

• FDA approval · 2013-03-21
  FDA Approved: SAPHRIS — Supplemental Application (Allergan, Inc.)

  The FDA approved Allergan's supplemental application for SAPHRIS (asenapine). The action approves an updated labeling related to a supplemen…

• FDA approval · 2013-03-01
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for GEODON (ziprasidone mesylate) submitted by Viatris Specialty LLC.

• FDA approval · 2013-03-01
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for GEODON (ziprasidone) submitted by Viatris Specialty LLC.

• FDA approval · 2013-02-28
  FDA Approved: ABILIFY MAINTENA — Original Application (Otsuka America Pharmaceutical, Inc.)

  The FDA approved ABILIFY MAINTENA (aripiprazole) through an Original Application (NDA202971) from Otsuka America Pharmaceutical, Inc.

• FDA approval · 2013-02-26
  FDA Approved: RISPERDAL CONSTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Risperdal Consta (risperidone) by Janssen, updating the labeling for the long-acting injecta…

• FDA approval · 2013-02-12
  FDA Approved: QUETIAPINE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories' generic quetiapine fumarate under an original ANDA, making a generic version of quetiapine available.

• FDA approval · 2013-02-06
  FDA Approved: VERSACLOZ — Original Application (TruPharma LLC)

  The FDA approved the original application for Versacloz (clozapine) from TruPharma LLC.