Business Services Industry
IVAX Receives Final Approval on Fluoxetine Tablets and Capsules
Business Wire, Oct 1, 2004
MIAMI -- IVAX Corporation (AMEX:IVX) (LSE:IVX.L) announced today that it has received final approval from the Federal Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for fluoxetine capsules in a 40 mg dosage and fluoxetine tablets in a 40 mg dosage. Fluoxetine is the generic equivalent of Prozac(R), which is marketed by Eli Lilly and used in the treatment of depression.
Prozac and fluoxetine are currently sold in 10 mg, 20 mg and 40 mg capsule dosages and 10 mg and 20 mg tablet dosages. IVAX' fluoxetine 40 mg tablet is a new dosage strength. According to IMS data, U.S. sales for Prozac and its generic equivalent, fluoxetine in all current dosage sizes and forms is approximately $481 million for the past twelve months ending June 30, 2004 and $185 million for Prozac and fluoxetine in 40 mg capsules for the past twelve months ending June 30, 2004. Fluoxetine 40 mg capsule and tablets will be launched by IVAX' wholly-owned subsidiary, IVAX Pharmaceuticals Inc.
IVAX continues its aggressive program to increase the number of products in its generic portfolio.
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.
Copies of this and other news releases may be obtained free of charge from IVAX' website at http://www.ivax.com.
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 fluoxetine capsules and tablets in 40mg strengths may be delayed; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; that IVAX' aggressive program to increase the number of products in its generic portfolio may not be successful; that IVAX may not file any additional ANDAs; 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. Prozac(R) is a registered trademark of Eli Lilly.
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