Tardive Dyskinesia

• EMA approval · 2026-01-23
  EMA Authorised: Austedo (deutetrabenazine) — Teva GmbH

  The European Medicines Agency authorised Austedo (deutetrabenazine) for the treatment of tardive dyskinesia, with Teva GmbH as the marketing…

• FDA approval · 2025-02-28
  FDA Approved: AUSTEDO XR — Supplemental Application (Teva Neuroscience, Inc.)

  FDA approved a supplemental application for AUSTEDO XR (deutetrabenazine) from Teva Neuroscience, Inc. The action involves the extended-rele…

• FDA approval · 2025-02-28
  FDA Approved: AUSTEDO — Supplemental Application (Teva Neuroscience, Inc.)

  FDA approved a supplemental application for Austedo (deutetrabenazine) from Teva Neuroscience, Inc. The approval updates the labeling for th…

• FDA approval · 2024-11-22
  FDA Approved: INGREZZA — Supplemental Application (Neurocrine Biosciences, Inc.)

  The FDA approved a supplemental application for INGREZZA (valbenazine) from Neurocrine Biosciences, Inc., resulting in an updated label for …

• FDA approval · 2024-07-01
  FDA Approved: AUSTEDO XR — Supplemental Application (Teva Neuroscience, Inc.)

  The FDA approved Teva's supplemental application for AUSTEDO XR (deutetrabenazine), an extended-release formulation of Austedo.

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• FDA approval · 2024-05-29
  FDA Approved: AUSTEDO XR — Supplemental Application (Teva Neuroscience, Inc.)

  FDA approved a supplemental application for AUSTEDO XR (deutetrabenazine) by Teva Neuroscience, expanding the product to include an extended…

• FDA approval · 2024-04-30
  FDA Approved: INGREZZA SPRINKLE — Original Application (Neurocrine Biosciences, Inc.)

  FDA approves INGREZZA SPRINKLE (valbenazine) via an original application for the treatment of tardive dyskinesia.

• FDA approval · 2023-09-28
  FDA Approved: AUSTEDO — Supplemental Application (Teva Neuroscience, Inc.)

  FDA approved a supplemental application for Austedo (deutetrabenazine) submitted by Teva Neuroscience, Inc. The approval updates the labelin…

• FDA approval · 2023-02-17
  FDA Approved: AUSTEDO XR — Original Application (Teva Neuroscience, Inc.)

  FDA approved AUSTEDO XR (deutetrabenazine) from Teva Neuroscience in an original NDA; the extended-release formulation targets symptoms of H…

• FDA approval · 2022-08-11
  FDA Approved: INGREZZA — Supplemental Application (Neurocrine Biosciences, Inc.)

  FDA approved a supplemental application for Ingrezza (valbenazine) from Neurocrine Biosciences. The approval expands the drug's labeling.

• FDA approval · 2021-02-09
  FDA Approved: AUSTEDO — Supplemental Application (Teva Neuroscience, Inc.)

  The FDA approved a supplemental application for Austedo (deutetrabenazine) from Teva Neuroscience, Inc., indicating an approved update to th…

• FDA approval · 2021-02-01
  FDA Approved: GOCOVRI — Supplemental Application (Adamas Pharma, LLC)

  FDA approved a supplemental application for GOCOVRI (amantadine) submitted by Adamas Pharma, LLC. The approval relates to the use of GOCOVRI…

• FDA approval · 2020-12-02
  FDA Approved: AUSTEDO — Supplemental Application (Teva Neuroscience, Inc.)

  FDA approves a supplemental application for Austedo (deutetrabenazine) from Teva Neuroscience, Inc.

• FDA approval · 2019-01-10
  FDA Approved: INGREZZA — Supplemental Application (Neurocrine Biosciences, Inc.)

  The FDA approved a supplemental application for INGREZZA (valbenazine) submitted by Neurocrine Biosciences. The action updates the drug's la…

• FDA approval · 2018-08-10
  FDA Approved: INGREZZA — Supplemental Application (Neurocrine Biosciences, Inc.)

  The FDA approved a supplemental application for INGREZZA (valbenazine) from Neurocrine Biosciences, Inc.

• FDA approval · 2017-04-11
  FDA Approved: INGREZZA — Original Application (Neurocrine Biosciences, Inc.)

  FDA approved INGREZZA (valbenazine) from Neurocrine Biosciences under NDA209241, marking the original approval for the treatment of tardive …

• FDA approval · 2015-06-03
  FDA Approved: XENAZINE — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for XENAZINE (tetrabenazine) submitted by Lundbeck Pharmaceuticals LLC.