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| December 27 , 2006 | ||||||
DR. REDDY’S ANNOUNCES FINAL APPROVAL OF ONDANSETRON TABLETS WITH 180-DAYS OF MARKETING EXCLUSIVITY December 27, 2006, Hyderabad, India: 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 Zofran® 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 Zofran® 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 Zofran® products pending a determination of its motion for a preliminary injunction. About Dr. Reddy’s Disclaimer Contact Information Dr. Reddy’s: Media: |
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