Date:28/12/2006 URL: http://www.thehindubusinessline.com/2006/12/28/stories/2006122801300200.htm

Dr Reddy's gets USFDA nod for Ondansetron

Our Bureau

Hyderabad , Dec. 27

Dr Reddy's Laboratories Ltd today got the final approval for Ondansetron Hydrochloride, the generic equivalent of the blockbuster drug `Zofran', from the US Food and Drug Administration (USFDA), as well as a 6-month marketing exclusivity.

The Hyderabad based pharma major announced that the USFDA has granted final approval for its Abbreviated New Drug Application (ANDA) for Ondansetron Hydrochloride Tablets in dosages of 4mg, 8mg, 16mg and 24mg.

Marketing exclusivity

As the first company to file an ANDA containing a paragraph IV certification for this product, the company has also been awarded a 180-day period of marketing exclusivity, a press release from the company said.

The company's Ondansetron Hydrochloride tablets are the AB-rated generic equivalent of GlaxoSmithKline's `Zofran' tablets, a product indicated for the prevention of nausea and vomiting associated with cancer treatment.

The brand product has annual IMS sales of approximately $639 million. Today's approval follows an order by the US Court of Appeals for the DC Circuit denying Apotexs request that the FDA not approve the company's generic Zofran products pending a determination of its motion for a preliminary injunction.

Dr Reddy's will commence the shipment of this product shortly. Mr G.V. Prasad, Vice-Chairman and CEO of the company, said, "We are 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 in 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."