Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced today that it has launchedTetrabenazine Tablets, a therapeutic equivalent generic version of Xenazine® (tetrabenazine)in the United States market approved by the U.S. Food and Drug Administration (USFDA).
The Xenazine® brand and generic had U.S. sales of approximately $322 million MAT for the most recent twelve months ending in November 2017 according to IMS Health*.
Dr. Reddy’s Tetrabenazine Tablets are available in strengths of 12.5 mg and 25 mg, each strength is available in a bottle count size of 112.
Xenazine® is a registered trademark of Valeant Pharmaceuticals Luxembourg S.A.R.L.
|WARNING: DEPRESSION AND SUICIDALITYSee full prescribing information for complete boxed warning.
• Increases the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease (5.1)
• Balance risks of depression and suicidality with the clinical need for control of chorea when considering the use of tetrabenazine (5.2)
• Monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior (5.1)
• Inform patients, caregivers and families of the risk of depression and suicidality and instruct to report behaviors of concern promptly to the treating physician (5.1)
• Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation (5.1)
• Tetrabenazine tablets are contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression (4, 5.1)