Healthcare Industry News: GSK
News Release - December 27, 2006
Dr. Reddy's Announces Final Approval of Ondansetron Tablets with 180-Days of Marketing ExclusivityHYDERABAD, India--(HSMN NewsFeed)--Dr. Reddy's Laboratories Limited (NYSE:RDY ) announced today, that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application ("ANDA") for Ondansetron Hydrochloride Tablets, 4 mg, 8mg, 16 mg and 24 mg. As the first company to file an ANDA containing a paragraph IV certification for this product, Dr. Reddy's has been awarded a 180-day period of marketing exclusivity. The Company will commence the shipment of this product shortly.
GV Prasad, Vice-Chairman and CEO of Dr. Reddy's commented, "We are obviously pleased with the final approval of our generic version of ZofranŽ with 180-days of marketing exclusivity. With six product introductions to date in the current year, we are making good progress in building a sustainable base generics business with potential upsides in the US in the medium term. This reaffirms our commitment to developing one of the largest pipelines in the U.S. generic industry."
Dr. Reddy's Ondansetron Hydrochloride Tablets are the AB-rated generic equivalent of GSK's ZofranŽ Tablets, a product indicated for the prevention of nausea and vomiting associated with cancer treatment. The brand product has annual IMS sales (June 2006 MAT) of approximately $639 million.
Today's approval follows an order by the United States Court Of Appeals for the DC Circuit denying Apotex's request that the FDA not approve Dr. Reddy's generic ZofranŽ products pending a determination of its motion for a preliminary injunction.
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, anti-infectives, inflammation and cancer.
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.
Source: Dr. Reddy's Laboratories
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