Bipolar Disorder

• FDA approval · 2020-11-09
  FDA Approved: OLANZAPINE — Supplemental Application (Dr. Reddy's Laboratories Ltd.)

  FDA approved a supplemental application for olanzapine from Dr. Reddy's Laboratories, establishing a generic version of the drug. The action…

• FDA approval · 2020-11-09
  FDA Approved: OLANZAPINE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  The FDA approved a supplemental application for olanzapine filed by Dr. Reddy's Laboratories Inc., indicating regulatory approval related to…

• FDA approval · 2020-10-30
  FDA Approved: PALIPERIDONE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for paliperidone (generic) submitted by NorthStar RxLLC.

• FDA approval · 2020-10-30
  FDA Approved: QUETIAPINE EXTENDED RELEASE — Supplemental Application (ACI Healthcare USA, Inc.)

  FDA approves a supplemental application for a generic quetiapine extended-release product by ACI Healthcare USA, Inc.

• FDA approval · 2020-10-30
  FDA Approved: VALPROIC ACID — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Valproic Acid submitted by ANI Pharmaceuticals, Inc.

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• FDA approval · 2020-10-29
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2020-10-28
  FDA Approved: RISPERIDONE — Supplemental Application (Natco Pharma USA LLC)

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

• FDA approval · 2020-10-26
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries Inc)

  FDA approved a generic version of chlorpromazine hydrochloride under Original Application for Sun Pharmaceutical Industries Inc, expanding a…

• FDA approval · 2020-10-22
  FDA Approved: OLANZAPINE — Original Application (Eugia US LLC)

  FDA approved the Original Application for olanzapine submitted by Eugia US LLC. The approval covers a generic olanzapine product indicated f…

• FDA approval · 2020-10-19
  FDA Approved: RISPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for risperidone by Amneal Pharmaceuticals LLC.

• FDA approval · 2020-10-09
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Lamictal (lamotrigine) from GlaxoSmithKline LLC. The action typically involves changes to la…

• FDA approval · 2020-10-09
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Lamictal (lamotrigine) filed by GlaxoSmithKline, leading to changes in the product labeling.

• FDA approval · 2020-10-09
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal ODT (lamotrigine) submitted by GlaxoSmithKline LLC.

• FDA approval · 2020-10-09
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal XR (lamotrigine) submitted by GlaxoSmithKline LLC. The action relates to Lamictal XR un…

• FDA approval · 2020-09-11
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for lithium carbonate from Glenmark Pharmaceuticals, approving a supplemental filing related to …

• FDA approval · 2020-09-09
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for lithium carbonate from Glenmark Pharmaceuticals Inc., USA, regarding the approved product.

• FDA approval · 2020-08-31
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2020-08-19
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal (lamotrigine) from GlaxoSmithKline.

• FDA approval · 2020-08-19
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal (lamotrigine) filed by GlaxoSmithKline LLC.

• FDA approval · 2020-08-19
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal ODT (lamotrigine) from GlaxoSmithKline LLC, adding or updating the orally disintegratin…

• EMA approval · 2020-07-31
  EMA Authorised: Olazax (olanzapine) — Glenmark Pharmaceuticals s.r.o.

  Olazax (olanzapine) has been authorised for schizophrenia and bipolar disorder in the European Union.

• FDA approval · 2020-07-13
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Lithium Carbonate by Rising Pharma Holdings, Inc., updating the approved labeling/indication fra…

• EMA approval · 2020-06-16
  EMA Authorised: Olazax Disperzi (olanzapine) — Glenmark Pharmaceuticals s.r.o.

  Authorised olazax disperzi (olanzapine) for schizophrenia and bipolar disorder in the EU.

• FDA approval · 2020-06-09
  FDA Approved: LAMOTRIGINE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Lamotrigine from Amneal Pharmaceuticals LLC, authorizing a new generic lamotrigine product.

• FDA approval · 2020-05-19
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) from AbbVie, updating labeling/indications for the pr…