deutetrabenazine

FDA Drug Profile — AUSTEDO XR, AUSTEDO

Drug Details

Generic Name
deutetrabenazine
Brand Names
AUSTEDO XR, AUSTEDO
Application Number
NDA216354
Sponsor
Teva Neuroscience, Inc.
NDC Codes
10
Dosage Forms
TABLET, FILM COATED, EXTENDED RELEASE, KIT
Routes
ORAL
Active Ingredients
DEUTETRABENAZINE

Indications and Usage

1 INDICATIONS AND USAGE AUSTEDO XR ® and AUSTEDO ® are indicated in adults for the treatment of: chorea associated with Huntington’s disease [see Clinical Studies ( 14.1 )] tardive dyskinesia [see Clinical Studies ( 14.2 )] AUSTEDO XR and AUSTEDO are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated in adults for the treatment of: Chorea associated with Huntington’s disease ( 1 ) Tardive dyskinesia ( 1 )