Teva Pharmaceutical gets FDA approval for AUSTEDO XR for TD and HD

Teva Pharmaceutical Industries said that its US affiliate Teva Pharmaceuticals has secured approval for AUSTEDO XR (deutetrabenazine) extended-release tablets from the US Food and Drug Administration (FDA) for tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD).

AUSTEDO XR is a new daily once formulation. Expected to be launched in the US later this year, AUSTEDO XR is an additional formulation of the currently marketed AUSTEDO, administered daily twice.

AUSTEDO is a vesicular monoamine transporter 2 (VMAT2) inhibitor.

Teva Pharmaceutical gets FDA approval for AUSTEDO XR for TD and HD. Photo courtesy of Raysonho @ Open Grid Scheduler / Scalable Grid Engine / Wikimedia Commons.

Eric Hughes — Teva Pharmaceutical Industries Executive Vice President of R&D and Chief Medical Officer said: “The approval of AUSTEDO XR is a reflection of our ongoing innovation for people living with TD and HD chorea.

“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.”

According to Teva Pharmaceutical Industries, daily once AUSTEDO XR has been demonstrated to be equivalent therapeutically to AUSTEDO.

AUSTEDO XR, which can be taken with or without food, will be available in three extended-release tablet strengths of 6mg, 12mg, and 24mg.