Dr Reddy’s announces the launch of Over-the-Counter fexofenadine HCl tablets
Hyderabad, India, April 14, 2011:
Dr. Reddy’s Laboratories (NYSE: RDY) announced today that it has launched its over-the-counter (OTC) fexofenadine HCl tablets on April 13, 2011. The Food & Drug Administration (FDA) approved Dr. Reddy’s Abbreviated New Drug Application (ANDA) for fexofenadine HCl tablets on April 12, 2011
Dr. Reddy’s will market the product under store brand labels in the U.S. market. The products are bioequivalent versions of sanofi-aventis’ Allegra® tablets which received Rx-to-OTC switch approval from the FDA on January 24th, 2011. The fexofenadine HCl Rx market had brand and generic sales of approximately $452 million for the twelve months ending December 31, 2010 according to IMS Health.
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.
Allegra® is a registered trademark of sanofi-aventis.
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
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