News | June 8, 2011

Dr. Reddy's Announces Three Generic Product Launches In The US Market

Dr. Reddy's Laboratories recently announced that it has launched the following three products in the US market:

  • Donepezil Hydrochloride tablets (5mg and 10mg strengths), a bioequivalent generic version of ARICEPT tablets. The Food & Drug Administration (FDA) approved Dr. Reddy's ANDA for Donepezil HCl tablets on May 31, 2011. Both strengths of Dr. Reddy's Donepezil Hydrochloride tablets are available in 30, 90 and 500 count bottles.
  • Venlafaxine Hydrochloride Extended Release capsules (37.5mg, 75mg and 150mg strengths), a bioequivalent generic version of EFFEXOR XR Extended Release capsules. The Food & Drug Administration (FDA) approved Dr. Reddy's ANDA for Venlafaxine Hydrochloride Extended Release Capsules on May 05, 2011. All three strengths of Dr. Reddy's Venlafaxine Hydrochloride Extended Release Capsules are available in 30, 90 and 500 count bottles.
  • Letrozole tablets, USP (2.5mg), a bioequivalent generic version of FEMARA. The Food & Drug Administration (FDA) approved Dr. Reddy's ANDA for Letrozole tablets, USP on June 3, 2011. Dr. Reddy's Letrozole tablets, USP are available in 30 count bottles.

Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of venlafaxine hydrochloride extended-release capsules or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Venlafaxine hydrochloride extended-release capsules are not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use)

About Dr. Reddy's
Dr. Reddy's Laboratories Ltd. is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania, and New Zealand. For more information, visit www.drreddys.com

SOURCE: Dr. Reddy's Laboratories