Dr. Reddy’s Announces Three Generic Product Launches in the US Market

HYDERABAD, India--(BUSINESS WIRE)-- Dr. Reddy’s Laboratories (NYSE: RDY) today 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.

Notes to the editor:

  • The ARICEPT® brand and Donepezil Hydrochloride tablets generic had total combined U.S. sales of approximately $2.3 billion for the twelve months ending March 31, 2011 according to IMS Health.
  • The EFFEXOR XR® brand and Venlafaxine Extended Release Capsules generic had total combined U.S. sales of approximately $2.3 billion for the twelve months ending March 31, 2011 according to IMS Health.
  • The FEMARA® brand had U.S. sales of approximately $702 million for the twelve months ending March 31, 2011 according to IMS Health.

IMS National Sales Perspectives: Retail and Non-Retail MAT 03/31/2011
*ARICEPT®, is a registered Trademark of Eisai R&D Management Co. Ltd.
**EFFEXOR XR®, is a registered Trademark of Wyeth, LLC
***FEMARA®, is a registered Trademark of Novartis Corporation

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)

Disclaimer

This press release includes forward-looking statements, as defined in the U.S. Private Securities Litigation Reform Act of 1995. We have based these forward-looking statements on our current expectations and projections about future events. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. Such factors include, but are not limited to, changes in local and global economic conditions, our ability to successfully implement our strategy, the market acceptance of and demand for our products, our growth and expansion, technological change and our exposure to market risks. By their nature, these expectations and projections are only estimates and could be materially different from actual results in the future.

About Dr. Reddy’s

Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) 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, log on to: www.drreddys.com.



CONTACT:

Dr. Reddy’s Laboratories Ltd.
Investors and Financial Analysts:
Kedar Upadhye, +91-40-66834297
[email protected]
or
Raghavender R, +91-40-49002135
[email protected]
or
Milan Kalawadia (USA), 908-203-4931
[email protected]
or
Media:
S Rajan, +91-40- 49002445
[email protected]

KEYWORDS:   United States  Asia Pacific  North America  New York  India

INDUSTRY KEYWORDS:   Health  Pharmaceutical  Research  Medical Supplies  Science  General Health

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