Business Services Industry
IVAX Receives Final Approval on Clozapine Tablet
Business Wire, Dec 19, 2005
MIAMI -- IVAX Corporation (AMEX:IVX) (LSE:IVX.L) (WSE:IVX) announced today that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for clozapine tablets USP, 200 mg. This product will be sold through IVAX' wholly owned subsidiary, IVAX Pharmaceuticals, Inc.
Clozapine is the generic equivalent of Clozaril(R) which is marketed by Novartis and used in the treatment of schizophrenia. The drug is currently available in 100, 50, 25 and 12.5 mg tablet dosage strengths. The 200 mg tablet is a new dosage strength developed by IVAX to create additional dosing options. According to IMS data, annual U.S. sales for Clozaril and its generic equivalent clozapine were $135.5 million for the twelve months ended September 30, 2005. IVAX currently has a market share of 53% of the total (Clozaril and its generic equivalent combined) market's extended units. E[acute accent]IVAX Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the U.S. and internationally. E[acute accent]Copies of this and other news releases may be obtained free of charge from IVAX' website at http://www.ivax.com. E[acute accent]Except for the historical matters contained herein, statements in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements, including the statements regarding IVAX' generic portfolio, involve risks and uncertainties which may affect the company's business and prospects, including the risks that the launch of clozapine tablets in 200 mg strength may be delayed; that IVAX may not be able to maintain its market share of the total clozapine market; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; and other risks and uncertainties based on economic, competitive, governmental, technological and other factors discussed in the Company's Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission. Clozaril(R) is a registered trademark of Novartis Pharmaceuticals Corporation.
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