ADVFN Logo ADVFN

We could not find any results for:
Make sure your spelling is correct or try broadening your search.

Trending Now

Toplists

It looks like you aren't logged in.
Click the button below to log in and view your recent history.

Hot Features

Registration Strip Icon for default Register for Free to get streaming real-time quotes, interactive charts, live options flow, and more.

IVX Innosis Ecological Ag

0.00
0.00 (0.00%)
- - Realtime Data
Share Name Share Symbol Market Type
Innosis Ecological Ag TG:IVX Tradegate Ordinary Share
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 0.00 -

Response to - IVAX Responds to First to File Reports-Metformin ER

22/10/2003 8:00am

UK Regulatory


    IVAX Corporation
David Malina, 305/575-6043

        IVAX Responds To First To File Reports On Metformin ER

In response to reports citing that IVAX Corporation (AMEX:IVX)
(LSE:IVX.L) will receive "first to file" status from the FDA for
Metformin ER, the generic equivalent of Bristol-Myers Squibb's
Glucophage XR(R), IVAX' Vice Chairman and President, Neil Flanzraich
said, "The FDA doesn't announce 'first to file' standing prior to
awarding a company final approval for a generic; however, if we were
to receive 'first to file' position on Metformin ER, it is a product,
like others in our pipeline, that will make a significant contribution
to IVAX' earnings."

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 involve
risks and uncertainties which may affect the company's business and
prospects including the risks that IVAX may not be the first to file
on metformin ER; that regulatory approval for metformin ER may be
delayed or not received or that the product may not be successfully
commercialized; that metformin ER may not make a significant
contribution to IVAX' earnings even if it receives first to file
status; that exclusivity periods and the launch of metformin ER may be
challenged by third parties, including challenges regarding patent
infringement; the difficulty in predicting the timing of FDA approvals
and the FDA's or other administrative or judicial agency's decisions
on exclusivity periods; 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 the compounds and products in
IVAX' generic pipeline will not be successfully developed, will not
receive regulatory approval or 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. Glucophage XR(R) is a registered
trademark of Bristol-Myers Squibb Company.

1 Year Innosis Ecological Chart

1 Year Innosis Ecological Chart

1 Month Innosis Ecological Chart

1 Month Innosis Ecological Chart

Your Recent History

Delayed Upgrade Clock