Regulatory Approval
August 01 2003 - 12:39PM
UK Regulatory
BW20030801002041 20030801T153936Z UTC
( BW)(IVAX-CORPORATION)(IVX) Regulatory Approval
Business Editors
UK REGULATORY NEWS
LONDON--(BUSINESS WIRE)--Aug. 1, 2003--
IVAX Receives Tentative Approval For Pravastatin Sodium
IVAX Corporation (AMEX:IVX) (LSE:IVX.L) announced today that it
received tentative approval from the FDA for its Abbreviated New Drug
Application (ANDA) for pravastatin sodium tablets in 10 mg, 20 mg and
40 mg dosage strengths. Upon final approval, this product will be sold
through the company's wholly owned subsidiary, IVAX Pharmaceuticals,
Inc. Pravastatin sodium is the generic equivalent of Pravachol(R),
which is marketed by the Bristol-Myers Squibb Company and is
prescribed for people with high cholesterol or heart disease. U.S.
sales of Pravachol tablets, in 10 mg, 20 mg and 40 mg strengths, were
$1.75 billion for the past twelve months, ending March 31, 2003.
IVAX currently has 39 ANDAs pending at the FDA. The company continues
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 final approval of IVAX' ANDA for pravastatin sodium tablets in 10
mg, 20 mg and 40 mg 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; 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.
Pravachol(R) is a registered trademark of Bristol-Myers Squibb.
Short Name: IVAX Corporation
Category Code: REA
Sequence Number: 00007909
Time of Receipt (offset from UTC): 20030801T161922+0100
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CONTACT: IVAX Corporation
KEYWORD: UNITED KINGDOM INTERNATIONAL EUROPE
INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL
SOURCE: IVAX Corporation
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