DR. REDDY'S ANNOUNCES FINAL APPROVAL OF ONDANSETRON TABLETS WITH 180-DAYS OF MARKETING EXCLUSIVITY

Dr. Reddy's Laboratories announced Dec. 27, that the FDA has granted final approval for the company's abbreviated new drug application (ANDA) for ondansetron hydrochloride tablets, 4 mg, 8 mg, 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.

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.

The approval follows an order by the U.S. Court Of Appeals for the D.C. 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.