Bipolar Disorder

• FDA approval · 2013-03-06
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol (carbamazepine) submitted by Novartis Pharmaceuticals Corporation.

• 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 · 2013-02-27
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

  The FDA approved AbbVie's supplemental application for DEPAKOTE (divalproex sodium), updating regulatory labeling as part of the supplementa…

• 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.

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• FDA approval · 2013-01-18
  FDA Approved: LAMOTRIGINE EXTENDED RELEASE — Original Application (Par Health USA, LLC)

  The FDA approved Par Health USA, LLC's Lamotrigine Extended Release as a new generic product under an original ANDA.

• FDA approval · 2012-12-31
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for a generic olanzapine and fluoxetine product. This expands access to the olanzapine/fluo…

• 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 · 2012-12-26
  FDA Approved: LAMOTRIGINE EXTENDED-RELEASE — Original Application (Par Health USA, LLC)

  The FDA approved Par Health USA, LLC's Lamotrigine Extended-Release as an original-application generic, to be marketed for the approved epil…

• 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…

• 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 · 2012-11-13
  FDA Approved: EQUETRO — Supplemental Application (Validus Pharmaceuticals LLC)

  The FDA approved a supplemental application for EQUETRO (carbamazepine) submitted by Validus Pharmaceuticals LLC.

• 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 · 2012-08-02
  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 · 2012-08-01
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal (lamotrigine) from GlaxoSmithKline LLC. This action may involve labeling or indication …

• FDA approval · 2012-08-01
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL ODT (lamotrigine) by GlaxoSmithKline LLC, updating the labeling for the oral disintegra…

• FDA approval · 2012-08-01
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL XR (lamotrigine) submitted by GlaxoSmithKline LLC.

• 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.