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IVX Innosis Ecological Ag

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Share Name Share Symbol Market Type
Innosis Ecological Ag TG:IVX Tradegate Ordinary Share
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 0.00 -

IVAX Confirms First To File Status On Gabapentin Tablets In Certain Dosage Strengths; Responds To Inquiries Following Recent Alp

29/04/2003 7:21pm

UK Regulatory


     
BW20030429002178  20030429T172048Z UTC


( BW)(IVAX-CORPORATION)(IVX) IVAX Confirms First To File Status On
Gabapentin Tablets In Certain Dosage Strengths; Responds To Inquiries
Following Recent Alpharma/Apotex Court Decision

    Business Editors
    UK REGULATORY NEWS

    MIAMI--(BUSINESS WIRE)--April 29, 2003--

IVAX Corporation (AMEX:IVX) (LSE:IVX.L), in response to inquiries,
today confirmed that it believes that it has first to file status on
gabapentin tablets in 100 mg, 300 mg and 400 mg dosage strengths.
Gabapentin is the active ingredient in Neurontin(R) which is marketed
by Warner-Lambert, a unit of Pfizer Inc. Monday's decision by the U.S.
District Court for the District of Columbia upholding the FDA's
decision that Alpharma, and not Apotex, was the first to challenge
Pfizer's patent does not impact the status of IVAX' ANDA or its
ability to launch.

Neurontin is marketed by Warner-Lambert in 5 dosage strengths, 100 mg,
300 mg and 400 mg capsules, and 600 mg and 800 mg tablets. IVAX has
amended a previously filed ANDA to include tablets in 100 mg, 300 mg
and 400 mg dosage strengths and believes that it has first to file
status on gabapentin tablets in these strengths. Tablets in these
strengths are not currently marketed and, upon approval, IVAX plans to
market them to HMOs and other institutional purchasers as Gabaron(TM),
a lower priced brand alternative.

IVAX also has ANDAs pending for the 100 mg, 300 mg and 400 mg
capsules, and 600 mg and 800 mg tablets currently marketed by
Warner-Lambert, and was previously notified by the FDA that its ANDA
for the 100 mg, 300 mg and 400 mg capsules is approvable. Upon
receiving final approval IVAX will market these dosages as generic
equivalents through its subsidiary, IVAX Pharmaceuticals, Inc.

IVAX has 38 ANDAs pending at the FDA. The company is continuing its
aggressive filing schedule for new ANDA submissions.

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' pending ANDAs and filing
schedule for ANDA submissions, involve risks and uncertainties which
may affect the company's business and prospects, including the risks
that IVAX Pharmaceuticals may not receive final approval for
gabapentin tablets or capsules in any or all of the strengths or that
its launch will be delayed; that IVAX may not have first to file
status; the impact of FDA's or other administrative or judicial
agency's decisions on exclusivity periods; that IVAX may not receive
approval of its pending ANDAs, or that if approved, the products will
not be successfully commercialized; 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. Neurontin(R) is a registered
trademark of Warner-Lambert Company, a unit of Pfizer Inc.

   Short Name: IVAX Corporation
   Category Code: MSC
   Sequence Number: 00004395
   Time of Receipt (offset from UTC): 20030429T175626+0100

    --30--CP/mi* sm/uk*

    CONTACT: IVAX Corporation, Miami
             Jim Whitlow, 305/575-6043

    KEYWORD: FLORIDA UNITED KINGDOM INTERNATIONAL EUROPE
    INDUSTRY KEYWORD: PHARMACEUTICAL
    SOURCE: IVAX Corporation

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