Regulatory Application
March 07 2003 - 8:41AM
UK Regulatory
BW20030307000028 20030307T134106Z UTC
( BW)(IVAX-CORPORATION)(IVX) Regulatory Application
Business Editors
UK REGULATORY NEWS
MIAMI--(BUSINESS WIRE)--March 7, 2003--
- IVAX Submits Abbreviated New Drug Application For Generic
Equivalent Of Flonase
IVAX Corporation (AMEX:IVX) (LSE:IVX.L) announced today that it
has submitted an Abbreviated New Drug Application (ANDA) to the U.S.
Food and Drug Administration (FDA) for approval to market fluticasone
propionate aqueous nasal spray, 50mcg. Fluticasone propionate is a
synthetic corticosteroid anti-inflammatory drug used in the treatment
of the nasal symptoms of seasonal and perennial allergic and
nonallergic rhinitis in adults and pediatric patients 4 years of age
and older. It is the generic equivalent of GlaxoSmithKline's
Flonase(R). U.S. sales of Flonase were approximately $810 million
during the past year.
IVAX currently has 39 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' 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 tentative
approvals and filing schedule for ANDA submissions, involve risks and
uncertainties which may affect the company's business and prospects,
including the risks that the FDA may not accept IVAX' ANDA or approve
this product; the difficulty of predicting the timeliness or outcome
of product development efforts and the filing of regulatory
applications; that the launch of fluticasone propionate aqueous nasal
spray, 50mcg strengths will be delayed; that the compounds and
products in IVAX' research pipeline will not be successfully
developed, will not receive regulatory approval or will not be
successfully commercialized; 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. Flonase(R) is a
registered trademark of GlaxoSmithKline Corporation.
Short Name: IVAX Corporation
Category Code: RAP
Sequence Number: 00002591
Time of Receipt (offset from UTC): 20030307T131646+0000
--30--CP/mi*
CONTACT: IVAX Corporation, Miami
Jim Whitlow, 305/575-6043
KEYWORD: FLORIDA UNITED KINGDOM INTERNATIONAL EUROPE
INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL
SOURCE: IVAX Corporation
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