HYDERABAD, India & PRINCETON, N.J.--(BUSINESS WIRE)--Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced today that it has launched Tetrabenazine 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 SUICIDALITY
See 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)
Please click here for Full Prescribing Information including Boxed Warning.
*IMS National Sales Perspective: Retail and Non-Retail MAT November 2017
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com.
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