Drug Safety Information for AUSTEDO ()

Safety-related Labeling Changes for AUSTEDO (DEUTETRABENAZINE) Rx Drug: FDA Link

Required post-approval safety study:

To better assess the persistence of deutetrabenazine treatment for TD, perform a new trial or conduct a substudy in a currently ongoing trial in which subjects who have demonstrated an adequate response to deutetrabenazine are randomized to receive placebo or continue their current dose. Due Date: 2022-01-31

Original FDA Drug Approval Date for AUSTEDO: 2017-04-03

FDA Adverse Event Summary for AUSTEDO (not avail) Unavailable