FDA nod for new form of Teva's Austedo

18 February 2023

The US Food and Drug Administration (FDA) has approved Austedo XR (deutetrabenazine) extended-release tablets, a new once-daily formulation indicated in adults for tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD).

Developed by Israeli generics giant Teva Pharmaceutical Industries (NYSE/TASE: TEVA), Austedo XR is an additional formulation of the currently marketed twice-daily Austedo, which was approved by the FDA in 2017.

“The approval of Austedo XR is a reflection of our ongoing innovation for people living with TD and HD chorea,” said Dr Eric Hughes, executive vice president of R&D and chief medical Officer at Teva. “For some patients living with TD and HD, treatment adherence can be a challenge that this new once-daily dosing option can help to address,” he added.

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