HYDERABAD, India
Dr. Reddy’s Laboratories (NYSE: RDY) announced today that it has launched Divalproex Sodium Extended – Release Tablets, USP (250 mg and 500 mg), a therapeutic equivalent generic version of Depakote® ER (divalproex sodium) Tablet, Extended Release in the US market on August 19, 2013. Dr. Reddy’s ANDA for Divalproex Sodium Extended – Release Tablets, USP was approved by the United States Food & Drug Administration (USFDA).
The Depakote® ER brand and generic had combined U.S. sales of approximately $194 Million MAT for the most recent twelve months ending in June 2013 according to IMS Health*.
Dr. Reddy’s Divalproex Sodium Extended – Release Tablets, USP 250 mg are available in bottle count sizes of 100 and 500 mg are available in bottle count sizes of 100 and 500.
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WARNING: LIFE THREATENING ADVERSE REACTIONS |
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See full prescribing information for complete boxed warning. |
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• Hepatotoxicity, including fatalities, usually during first 6 months of treatment. Children under the age of two years are at considerably higher risk of fatal hepatotoxicity. Monitor patients closely, and perform liver function tests prior to therapy and at frequent intervals thereafter |
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• Fetal Risk, particularly neural tube defects and other major malformations |
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• Pancreatitis, including fatal hemorrhagic cases |
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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
Depakote® ER (divalproex sodium) Tablet, Extended Release is a trademark of Sanofi Corporation.
*IMS National Sales Perspectives: Retail and Non-Retail MAT June 2013
CONTACT
Dr. Reddy’s Laboratories Ltd.
Investors
and Financial Analysts:
Kedar Upadhye, +91-40-66834297
kedaru@drreddys.com
or
Saunak
Savla, +91-40-49002135
saunaks@drreddys.com
or
Milan
Kalawadia (USA), +1 908-203-4931
mkalawadia@drreddys.com
or
Media:
S
Rajan, +91-40-49002445
rajans@drreddys.com
