Regulatory Approval
01 August 2003 - 11:56PM
UK Regulatory
BW20030801000321 20030801T125626Z UTC
( BW)(IVAX-CORPORATION)(IVX) Regulatory Approval
Business Editors
UK REGULATORY NEWS
LONDON--(BUSINESS WIRE)--Aug. 1, 2003--
IVAX Receives Approval On Clozapine 12.5 Mg Tablets
IVAX Corporation (AMEX:IVX) (LSE:IVX.L) announced today that its
wholly owned subsidiary, IVAX Pharmaceuticals, Inc., has received
final FDA approval for its Abbreviated New Drug Application (ANDA) for
clozapine in a 12.5 mg tablet dosage.
Clozapine is the generic equivalent of Clozaril(R) which is marketed
by Novartis and used in the treatment of schizophrenia. U.S. sales for
Clozaril and its generic equivalent, clozapine, were $207.7 million
for the past twelve months, ending March 31, 2003. IVAX currently has
a market share of 43.4% of the total (Clozaril and clozapine combined)
market's extended units. The drug is sold in 100 mg and 25 mg tablet
dosage strengths. IVAX' 12.5 mg tablet is a new dosage strength
developed by IVAX to facilitate dose titration and minimize the risk
of side effects.
IVAX will manufacture the clozapine 12.5 mg tablets at its subsidiary
in Cidra, Puerto Rico and expects to market the tablets in 30 days.
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 the launch of clozapine in 12.5 mg strengths will be delayed;
that this product may not prove to have the perceived advantages or
reduced side effects over the other available dosage strengths;
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. Clozaril(R) is a registered
trademark of Novartis.
Short Name: IVAX Corporation
Category Code: REA
Sequence Number: 00007888
Time of Receipt (offset from UTC): 20030801T133248+0100
--30--CP/mi* KO/uk
CONTACT: IVAX Corporation
KEYWORD: UNITED KINGDOM INTERNATIONAL EUROPE
INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL
SOURCE: IVAX Corporation
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