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IVAX To Continue Selling Gabapentin Tablets: Pfizer's TRO Motion and Preliminary Injunction Denied.


MIAMI Miami, cities, United States
Miami (mīăm`ē, –ə).

1 City (1990 pop. 358,548), seat of Dade co., SE Fla., on Biscayne Bay at the mouth of the Miami River; inc. 1896.
 -- IVAX Corporation (AMEX AMEX

See: American Stock Exchange
:IVX) said that the Federal District Court in New Jersey denied the motion of plaintiff Pfizer Inc. for a temporary restraining order temporary restraining order: see injunction.  and preliminary injunction which sought to block the sale by IVAX IVAX Industrial Vax (Dec Computer)  of gabapentin tablets in 100 mg, 300 mg and 400 mg strengths. As a result, IVAX, through its U.S. generics subsidiary, IVAX Pharmaceuticals, Inc., will continue its launch of gabapentin tablets in 100 mg, 300 mg and 400 mg strengths, which commenced August 18, 2004.

IVAX received final approval of its Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar  for these tablets from the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 in April 2004. As the first company to file an ANDA ANDA
abbr.
abbreviated new drug application
 with a Paragraph IV patent certification, IVAX has been awarded 180-days marketing exclusivity for 100 mg, 300 mg and 400 mg tablets. Gabapentin is the generic name of Neurontin(R), approved to treat seizures and postherpetic neuralgia (PHN Postherpetic neuralgia (PHN)
The term used to describe the pain after the rash associated with herpes zoster is gone.

Mentioned in: Shingles

PHN Postherpetic neuralgia, see there
), and is marketed by Warner-Lambert, a unit of Pfizer Inc. Neurontin had U.S. sales of approximately $2.4 billion in 2003.

Neurontin is sold by Warner-Lambert in 5 dosage strengths: 100 mg, 300 mg and 400 mg capsules and 600 mg and 800 mg tablets. In addition to IVAX' first-to-file FDA approval for 100, 300 and 400 mg gabapentin tablets, IVAX has received a tentative approval from the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
 (FDA) for its ANDA for the 100 mg, 300 mg, and 400 mg capsules, and on the 600 mg and 800 mg tablets marketed by Warner-Lambert. Litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 with Pfizer concerning the Neurontin patent is pending and a trial 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 100 mg, 300 mg and 400 mg dosage strengths may be delayed or may be stopped at any time; that the products will not be successfully commercialized; that market acceptance for the tablet dosage form of gabapentin may not develop as anticipated; 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; that the patent litigation with respect to these products could prevent us from selling these products, could result in substantial damages which could exceed the expected profit or selling price for these products; the difficulty of predicting the timing of FDA approvals; the impact of decisions of the FDA or other administrative or judicial agencies on exclusivity periods; competitors' ability to extend exclusivity periods past initial patent terms; that final approval of IVAX' ANDA for the 100 mg, 300 mg and 400 mg capsules and the 600 mg and 800 mg tablets may be delayed or not received at all, and that if finally approved, the products will not be successfully commercialized; that IVAX may not increase the number of products in its generic portfolio; 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.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Aug 20, 2004
Words:635
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