Dr. Reddy’s Announces the Approval of Azacitidine for Injection

Tue Sep 17, 2013 2:43am EDT

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Dr. Reddy’s Announces the Approval of Azacitidine for Injection

Dr. Reddy’s Laboratories (NYSE: RDY) announced today that Azacitidine for Injection 100 mg/vial, a bioequivalent generic version of VIDAZA® (azacitidine for injection), is approved by the United States Food & Drug Administration (USFDA) on September 16, 2013. The launch of product in the market is planned in the near-term.

The VIDAZA® brand had U.S. sales of approximately $378.5 Million for the most recent twelve months ending July 2013 according to IMS Health.

Dr. Reddy’s Azacitidine for Injection 100 mg/vial is available in single-use vials.

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 and differentiated formulations. Major therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infective. Major markets include India, USA, Russia-CIS and Europe apart from other select geographies within Emerging Markets.

VIDAZA® is a registered trademark of Celgene Corporation.
IMS National Sales Perspectives: Retail and Non-Retail MAT July 2013

Dr. Reddy’s Laboratories Ltd.
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