Dr Reddy's announces final approval of Ondansetron tablets with 180-days of marketing exclusivity

Dr Reddys Laboratories Ltd on December 27, 2006 has announced that the US Food and Drug Administration has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) for Ondansetron Hydrochloride Tablets, 4mg, 8mg, 16mg and 24mg. As the first company to file an ANDA containing a paragraph IV certification for this product, the Company 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 the Company 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 US generic industry."

The Company's Ondansetron Hydrochloride Tablets are the AB-rated generic equivalent of GSKs 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 the Company's generic Zofran® products pending a determination of its motion for a preliminary injunction.

Source : Equity Bulls

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