Teva announces FDA approval of AUSTEDO XR tablets

Teva Pharmaceuticals announced that the U.S. Food and Drug Administration has approved AUSTEDO XR extended-release tablets, a new once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington’s disease. AUSTEDO XR is an additional formulation of the currently marketed twice-daily AUSTEDO. "The approval of AUSTEDO XR is a reflection of our ongoing innovation for people living with TD and HD chorea," said Eric Hughes, MD, PhD, 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." Once-daily AUSTEDO XR has been shown to be therapeutically equivalent to the twice-daily formulation, providing another effective treatment choice. It will be available in three extended-release tablet strengths – 6 mg, 12 mg, and 24 mg – and can be taken with or without food. The new tablet strengths provide an updated regimen which may result in a decreased pill count for patients compared to the twice-daily formulation.