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Biotech / Medical : IVX: IVAX Corporation

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To: Jim Oravetz who wrote (56)	12/10/2004 12:42:28 PM
From: Jim Oravetz	Read Replies (1) of 78

IVAX:Tentative Approval For Sertraline HCl(ZoloftTM) Tablets DOW JONES NEWSWIRES December 9, 2004 12:35 p.m. MIAMI -- Ivax Corp. (IVX) received tentative approval from the Food and Drug Administration for its abbreviated new drug application for Setraline HCI tablets - the generic equivalent of Pfizer Inc.'s (PFE) anti-depressant drug Zoloft. In a press release Thursday, the company said the ANDA for Sentraline HCI covers the 25 milligram, 50 mg and 100 mg dosage strengths. Ivax believes that it has first-to-file status on this drug and said it will be entitled to 180 days of marketing exclusivity. In 2002, Pfizer settled its infringement lawsuit with Ivax, and Ivax plans to launch this product in June 2006. According to IMS data, U.S. sales for Zoloft were $3.06 billion for the 12 months ended Sept. 30, Ivax said. Ivax makes branded and generic pharmaceuticals and veterinary products. Earlier this year, Ivax said an effort to block the sale of its generic version of Pfizer's blockbuster epilepsy drug Neurontin failed. American Stock Exchange-listed shares of Ivax were trading recently at $15.67, down 28 cents, or 1.8%.

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