Regulatory Approval
September 05 2003 - 2:00AM
UK Regulatory
BW20030904002105 20030905T060028Z UTC
( BW)(IVAX-CORPORATION)(IVX) Regulatory Approval
Business Editors
UK REGULATORY NEWS
MIAMI--(BUSINESS WIRE)--Sept. 5, 2003--
IVAX Receives Final Approval For Pergolide
IVAX Corporation (AMEX:IVX) (LSE:IVX.L) announced today that it has
received final approval for its Abbreviated New Drug Application
(ANDA) for pergolide mesylate tablets in .05 mg, .25 mg and 1 mg
dosage strengths and has begun marketing these tablets through the
company's wholly owned subsidiary, IVAX Pharmaceuticals, Inc.
Pergolide mesylate is the generic equivalent of Permax(R) tablets
marketed by Amarin Corporation PLC for use as an adjunctive treatment
in connection with Parkinson's disease. U.S. sales of Permax during
2002 were approximately $50 million. Pergolide mesylate tablets'
active pharmaceutical ingredient is produced at IVAX' facility in the
Czech Republic, which will also be manufacturing the tablets.
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 involve
risks and uncertainties which may affect the company's business and
prospects, including the risks that launch of pergolide mesylate
tablets in .05 mg, .25 mg and 1 mg 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; 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. Permax(R) is a registered
trademark of Eli Lilly and Company.
Short Name: IVAX Corporation
Category Code: REA
Sequence Number: 00009292
Time of Receipt (offset from UTC): 20030904T183050+0100
--30--JD/mi* DB/ny
CONTACT: IVAX Corporation, Miami
David Malina, 305-575-6043
KEYWORD: FLORIDA UNITED KINGDOM INTERNATIONAL EUROPE
INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL PRODUCT
SOURCE: IVAX Corporation
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