Dr. Reddy's receives USFDA approval for Ranitidine (Zantacâ„¢) Tablets, 150mg
First major approval for its U.S. OTC business
September 13, 2007, Hyderabad, India: Dr. Reddyâ€™s Laboratories announced today, that the U.S. Food and Drug Administration (USFDA) has granted final approval for the Companyâ€™s Abbreviated New Drug Application (ANDA) for Ranitidine (Zantacâ„¢) 150mg tablet (Over-the-Counter). The Company is the only generic manufacturer to receive FDA approval for this product following the expiry of innovatorâ€™s patents. This is the first approval for Dr. Reddyâ€™s U.S. OTC business unit following an announcement in mid-May, to launch a Store Brand OTC Division in the U.S.
Commenting on the approval, Mark Hartman, President, North America Generics said,
â€œWe are excited about the Ranitidine 150mg approval as it will complement our Ranitidine 75mg OTC entry. This approval will help establish Dr. Reddyâ€™s in the U.S. OTC business segment. The company has plans to expand its OTC product portfolio and additional introductions are planned in the coming months that will certainly include Rx switches and select OTC Monograph productsâ€.
The company will distribute the 150mg strength in blister counts of 8 and 24â€™s as well as bottles of 50, 65 and 95 counts.
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:
Established in 1984, Dr. Reddy's Laboratories (NYSE: RDY) is an emerging global pharmaceutical company with proven research capabilities. The Company is vertically integrated with a presence across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with focus on India, US, Europe and Russia. The Company conducts research in the areas of diabetes, cardiovascular and cancer.