Schizophrenia

• FDA approval · 2013-01-31
  FDA Approved: FANAPT — Supplemental Application (Vanda Pharmaceuticals Inc.)

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

• FDA approval · 2013-01-22
  FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)

  The FDA approved a supplemental application for Latuda (lurasidone hydrochloride) from Sumitomo Pharma America, Inc. to update the product l…

• FDA approval · 2012-12-31
  FDA Approved: RISPERIDONE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved a supplemental application for risperidone from Ajanta Pharma USA Inc., enabling a new generic risperidone product.

• FDA approval · 2012-12-20
  FDA Approved: RISPERIDONE — Supplemental Application (Amici Pharma, Inc.)

  FDA approves a supplemental application for risperidone from Amici Pharma, Inc.

• FDA approval · 2012-12-19
  FDA Approved: RISPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application from Amneal Pharmaceuticals LLC for risperidone (generic), marking an update to its approval und…

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• FDA approval · 2012-12-12
  FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for risperidone submitted by Zydus Lifesciences Limited.

• FDA approval · 2012-11-27
  FDA Approved: RISPERIDONE — Supplemental Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's generic risperidone through an ANDA, authorizing the generic product for the same indications as the brand.

• FDA approval · 2012-11-08
  FDA Approved: SAPHRIS — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for SAPHRIS (asenapine), resulting in labeling changes for the antipsychotic.

• FDA approval · 2012-10-29
  FDA Approved: RISPERIDONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for risperidone by Sun Pharmaceutical Industries, Inc. (ANDA 078474).

• FDA approval · 2012-10-22
  FDA Approved: RISPERIDONE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for risperidone from Aurobindo Pharma Limited (generic risperidone).

• FDA approval · 2012-10-18
  FDA Approved: RISPERIDONE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' supplemental application for risperidone under an ANDA, confirming approval of a change associated…

• FDA approval · 2012-09-12
  FDA Approved: OLANZAPINE — Original Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved the original application for olanzapine from Jubilant Cadista Pharmaceuticals Inc., providing a generic version of the antipsyc…

• FDA approval · 2012-09-05
  FDA Approved: ZIPRASIDONE — Original Application (Chartwell RX, LLC)

  FDA approved an original application for ziprasidone from Chartwell RX, LLC, enabling a new generic version of the antipsychotic.

• FDA approval · 2012-08-29
  FDA Approved: INVEGA SUSTENNA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approves a supplemental application for INVEGA SUSTENNA (paliperidone palmitate) submitted by Janssen Pharmaceuticals, extending/adjusti…

• FDA approval · 2012-08-03
  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 · 2012-08-02
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The U.S. FDA approved a supplemental application for Risperdal M-TAB (risperidone) submitted by Janssen Pharmaceuticals, Inc.

• FDA approval · 2012-07-27
  FDA Approved: RISPERIDONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for risperidone from Sun Pharmaceutical Industries under ANDA078474.

• FDA approval · 2012-05-22
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for haloperidol decanoate submitted by Fresenius Kabi USA, LLC. This action provides an addition…

• FDA approval · 2012-04-30
  FDA Approved: RISPERIDONE — Supplemental Application (Amici Pharma, Inc.)

  FDA approved a supplemental application for RISPERIDONE from Amici Pharma, Inc.

• FDA approval · 2012-04-23
  FDA Approved: OLANZAPINE — Original Application (Torrent Pharmaceuticals Limited)

  The FDA approved Torrent Pharmaceuticals Limited's original application for a generic olanzapine product, making a generic antipsychotic ava…

• FDA approval · 2012-04-23
  FDA Approved: OLANZAPINE — Original Application (Dr. Reddy's Laboratories Ltd.)

  FDA approves Dr. Reddy's Laboratories' generic olanzapine under an Original Abbreviated New Drug Application (ANDA).

• FDA approval · 2012-04-23
  FDA Approved: OLANZAPINE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved Dr. Reddy's Laboratories' original application for olanzapine, enabling a generic version of the antipsychotic.

• FDA approval · 2012-04-23
  FDA Approved: OLANZAPINE — Original Application (Aurobindo Pharma Limited)

  FDA approved the Original Application for a generic olanzapine product from Aurobindo Pharma Limited.

• FDA approval · 2012-04-23
  FDA Approved: OLANZAPINE — Original Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s generic olanzapine under an original ANDA. This marks approval of a generic version of olanzapine.

• FDA approval · 2012-03-27
  FDA Approved: QUETIAPINE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's generic quetiapine tablets through an Original Application. Quetiapine is approved for schizophrenia, bipolar disorder, …