Pharma Focus Asia

Teva Announces FDA Approval of AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets

Friday, February 17, 2023

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries announced that the U.S. Food and Drug Administration (FDA) has approved AUSTEDOXR (deutetrabenazine) extended-release tablets, a new once-daily formulation indicated in adults for tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD).  AUSTEDO XR is an additional formulation of the currently marketed twice-daily AUSTEDO.

AUSTEDO is the only vesicular monoamine transporter 2 (VMAT2) inhibitor approved for both tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD) indications. AUSTEDO is the only VMAT2 inhibitor with 3-year long-term data for both TD and HD chorea.

The approval of AUSTEDO XR is a reflection of ongoing innovation for people living with TD and HD chorea. For some patients living with TD and HD, treatment adherence has become a challenge and this new once-daily dosing option helps to address.

Once-daily AUSTEDO XR is therapeutically equivalent to the twice-daily formulation, providing another effective treatment choice. It is available in three extended-release tablet strengths – 6 mg, 12 mg, and 24 mg – and applicable with or without food. The new tablet strengths provide an updated regimen resulting in a decreased pill count for patients compared to the twice-daily formulation.

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