Dr. Reddy's Laboratories (RDY) Receives Final FDA Approval for Ondansetron Tablets with 180-Days of Marketing Exclusivity
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Dr. Reddy's Laboratories Limited (NYSE: RDY) announced 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.
Dr. Reddy's has been awarded a 180-day period of marketing exclusivity. The Company will commence the shipment of this product shortly.
Dr. Reddy's Ondansetron Hydrochloride Tablets are the AB-rated generic equivalent of GSK's (NYSE: GSK) 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.
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