Dr. Reddy’s Announces the Launch of Divalproex Sodium Extended - Release
HYDERABAD, India -- August 22, 2013
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.
WARNING: LIFE THREATENING ADVERSE REACTIONS
See full prescribing information for complete boxed warning.
• 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
• Fetal Risk, particularly neural tube defects and other major
• Pancreatitis, including fatal hemorrhagic cases
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
*IMS National Sales Perspectives: Retail and Non-Retail MAT June 2013
Dr. Reddy’s Laboratories Ltd.
Investors and Financial Analysts:
Kedar Upadhye, +91-40-66834297
Saunak Savla, +91-40-49002135
Milan Kalawadia (USA), +1 908-203-4931
S Rajan, +91-40-49002445
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