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IVAX Receives Final Approval on 600 and 800 mg Gabapentin Tablets
Business Wire, May 2, 2005
MIAMI -- IVAX Corporation (AMEX:IVX) (LSE:IVX.L) (WSE:IVX) announced today that it received final approval on April 29, 2005 from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for gabapentin 600 and 800 mg tablets. Upon FDA approval, IVAX' wholly owned subsidiary, IVAX Pharmaceuticals, Inc., launched this product. Gabapentin is the generic equivalent of Neurontin(R) which is marketed by Warner-Lambert, a unit of Pfizer, Inc. to treat seizures and postherpetic neuralgia (PHN). According to IMS data, U.S. sales for gabapentin 600 and 800 mg tablets and Neurontin 600 and 800 mg Tablets in 2004 were $1.1 billion.
In February, 2005, IVAX entered into a settlement of litigation with the FDA and Alpharma, Inc. regarding gabapentin. Pursuant to the settlement, Alpharma waived its FDA awarded 180-day exclusivity in favor of IVAX, effective on March 23, 2005 for gabapentin 100, 300 and 400 mg capsules and April 29, 2005 for gabapentin 600 and 800 mg tablets. IVAX launched its gabapentin 100, 300 and 400 mg capsules on March 23, 2005.
On August 18, 2004, IVAX launched its non-AB rated gabapentin 100, 300, and 400 mg tablets for which IVAX was awarded 180-days of marketing exclusivity. Neurontin is sold by Warner-Lambert in 5 dosage strengths: 100, 300 and 400 mg capsules and 600 and 800 mg tablets. Gabapentin 100, 300 and 400 mg tablets had not previously been marketed and IVAX remains the only company selling gabapentin in 100, 300 and 400 mg tablet form.
IVAX is presently litigating whether its gabapentin products infringe a patent held by Pfizer. A trial in the U.S. District Court of New Jersey has not yet been scheduled.
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 involve risks and uncertainties which may affect the company's business and prospects, including the risks that launch of gabapentin tablets in 600 mg and 800 mg dosage strengths may be delayed or may not occur, and if launched, the products will not be successfully commercialized; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; the difficulty in predicting the timing and outcome of legal proceedings, including the outcome of Pfizer's patent infringement claim against IVAX and others with respect to gabapentin; 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. Neurontin(R) is a registered trademark of Warner-Lambert Company, a unit of Pfizer Inc.
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