MIAMI – February 19, 2004 – IVAX Corporation (AMEX: IVX, LSE: IVX.L) received final approval and confirmation of its first to file status from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for glyburide/metformin HCl tablets. The generic product will be marketed by the company’s wholly owned subsidiary, IVAX Pharmaceuticals, Inc. Glyburide/metformin HCl is the generic equivalent of Glucovance® which is marketed by Bristol-Myers Squibb as an initial and second line therapy for Type 2 diabetes. U.S. sales for Glucovance were almost $500 million in 2003. IVAX Pharmaceuticals is building inventory, and information about the timing of the launch of this product will follow.
IVAX’ pipeline now consists of 43 ANDAs pending with the FDA of which 9 are potentially first-to-file submissions with U.S. brand sales of approximately $13 billion. IVAX continues its aggressive program to increase the numbers of products in its generic portfolio.
Source: IVAX Corporation