Bipolar Disorder

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

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

• 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 · 2013-07-31
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote ER (divalproex sodium) from AbbVie Inc. This action represents an approved supplement t…

• 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 · 2013-07-29
  FDA Approved: TEGRETOL XR — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol XR (carbamazepine) by Novartis Pharmaceuticals Corporation, typically resulting in upda…

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• 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 · 2013-07-15
  FDA Approved: LAMOTRIGINE — Original Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved Amneal Pharmaceuticals of New York LLC's original ANDA for lamotrigine, a generic version of the anticonvulsant. The approv…

• 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 · 2013-07-09
  FDA Approved: EPITOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for EPITOL (carbamazepine) filed by Teva Pharmaceuticals USA, Inc., under ANDA070541.

• 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 · 2013-06-19
  FDA Approved: LAMOTRIGINE — Original Application (NorthStar Rx LLC)

  FDA approved NorthStar Rx LLC's generic Lamotrigine under an Original Application (ANDA) for use in treating epilepsy and bipolar disorder.

• FDA approval · 2013-06-14
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for DEPAKOTE ER (divalproex sodium) submitted by AbbVie Inc.

• FDA approval · 2013-06-14
  FDA Approved: LAMOTRIGINE — Original Application (Ascend Laboratories, LLC)

  FDA approves Ascend Laboratories, LLC's original ANDA for lamotrigine, enabling the marketing of a lamotrigine generic product.

• 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 · 2013-06-13
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for carbamazepine from Sun Pharmaceutical Industries, Inc., indicating an update to the product's re…

• FDA approval · 2013-06-13
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for carbamazepine submitted by Sun Pharmaceutical Industries, Inc.

• 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 · 2013-04-22
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Teva Pharmaceuticals USA, Inc. to market the olanzapine and fluoxetine combination (OLANZAPINE A…

• FDA approval · 2013-03-25
  FDA Approved: OLANZAPINE AND FLUOXETINE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's olanzapine and fluoxetine combination as an original ANDA generic product for depressive episodes in bipolar I disorder …

• 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 · 2013-03-14
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for a generic olanzapine and fluoxetine combination submitted by Par Health USA, LLC. The product is…