Regulatory Approval
26 April 2003 - 3:07AM
UK Regulatory
BW20030425002048 20030425T160718Z UTC
( BW)(IVAX-CORPORATION)(IVX) Regulatory Approval
Business Editors
UK REGULATORY NEWS
LONDON--(BUSINESS WIRE)--Aril 25, 2003--
IVAX Corporation (AMEX:IVX) (LSE:IVX.L) announced today it has
received tentative approval from the FDA of its Abbreviated New Drug
Application (ANDA) for pergolide mesylate tablets in .05mg, .25mg
and 1mg strengths. Upon final approval, this product will be sold
through the company's wholly owned subsidiary, IVAX Pharmaceuticals,
Inc. Pergolide mesylate is used as adjunctive treatment in connection
with Parkinson's disease. It is the generic equivalent of Permax(R)
tablets marketed by Amarin Corporation PLC. U.S. sales of Permax
during 2002 were approximately $50 million.
IVAX currently 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' web site at http://www.ivax.com.
The "FDA" refers to the United States Food and Drug
Administration.
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 final approval of IVAX' ANDA for pergolide mesylate tablets in
.05mg, .25mg and 1mg strengths may be delayed or not received at
all; that launch of the tablets 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 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 2001 Annual
Report on Form 10-K and its other filings with the Securities and
Exchange Commission. Permax(R) is a registered trademark of Eli Lilly
and Company.
Short Name: IVAX Corporation
Category Code: REA
Sequence Number: 00004303
Time of Receipt (offset from UTC): 20030425T163659+0100
--30--JD/mi* ne/uk
CONTACT: IVAX Corporation
KEYWORD: UNITED KINGDOM INTERNATIONAL EUROPE
INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL
SOURCE: IVAX Corporation
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