Regulatory Approval
June 18 2003 - 9:47AM
UK Regulatory
BW20030618002043 20030618T124702Z UTC
( BW)(IVAX-CORPORATION)(IVX) Regulatory Approval
Business Editors
UK REGULATORY NEWS
MIAMI--(BUSINESS WIRE)--June 18, 2003--
IVAX Receives Tentative Approval For
Nefazodone HCI Tablets
IVAX Corporation (AMEX:IVX) (LSE:IVX.L) announced today that it has
received tentative approval from the FDA for its Abbreviated New Drug
Application (ANDA) for nefazodone hydrochloride tablets in 50 mg, 100
mg, 150 mg, 200 mg and 250 mg strengths. Upon final approval, this
product will be sold through the company's wholly owned subsidiary,
IVAX Pharmaceuticals, Inc. Nefazodone hydrochloride tablets are the
generic equivalent of Serzone(R) tablets, marketed by Bristol-Myers
Squibb for the treatment of depression. U.S. sales of Serzone for the
past twelve months, ending with the first quarter of 2003, were $237
million.
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.
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 nefazodone hydrochloride tablets
in 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg strengths may be delayed
or not received at all; that launch of the tablets may be delayed;
that the FDA may place restrictions upon or prohibit the sale of the
product; that litigation relating to the warnings contained in the
product label may impact the sales of this product; 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 Annual
Report on Form 10-K and its other filings with the Securities and
Exchange Commission. Serzone(R) is a registered trademark of
Bristol-Myers Squibb.
Short Name: IVAX Corporation
Category Code: REA
Sequence Number: 00006078
Time of Receipt (offset from UTC): 20030618T132041+0100
--30--JD/mi* KO/uk
CONTACT: IVAX Corporation
KEYWORD: UNITED KINGDOM INTERNATIONAL EUROPE
INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL
SOURCE: IVAX Corporation
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