Dr Reddy's receives FDA approval for generic Zofran

12/28/06 - newratings.com

LONDON, December 28 (newratings.com) – Drugmaker Dr Reddy's Laboratories Ltd (RDY) Wednesday announced that it had received final approval for its generic version of Zofran from the US Food and Drug Administration (FDA).

The Indian company said it had received approval from the FDA to market ondansetron hydrochloride tablets, which are marketed by GlaxoSmithKline Plc (GSK) under the Zofran brand name for the prevention of nausea and vomiting caused by chemotherapy and anesthesia. With the approval, the company can exclusively market ondansetron hydrochloride tablets in the US for the next 180 days, Dr Reddy's Laboratories added. The company will commence shipment of this product in the dosage spectrum of 4 mg, 8mg, 16 mg and 24 mg.