FDA approves extension of expiration date for TAXUS(TM) Express2(TM) paclitaxel-eluting stent system to nine months
19 August 2004 - 8:14PM
PR Newswire (US)
FDA approves extension of expiration date for TAXUS(TM)
Express2(TM) paclitaxel-eluting stent system to nine months
Decision adds three months to current U.S. shelf life of product
VANCOUVER, Aug. 19 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP) corporate
partner, Boston Scientific, today announced that the U.S. Food and
Drug Administration (FDA) has approved extending the shelf life of
its TAXUS Express2 paclitaxel-eluting coronary stent system in the
United States to nine months from the current shelf life of six
months. The decision was based on data submitted by Boston
Scientific to the FDA that demonstrated the performance of the
TAXUS system - in particular the drug content, drug degradation
profile, and drug-release mechanism - was maintained within FDA-
approved specifications at nine months. The extended expiration
date applies to all sizes of the TAXUS system for sale in the
United States. Boston Scientific said it would immediately begin
updating labels to reflect the nine-month expiration date. The
shelf life for the TAXUS system outside the United States remains
unchanged at 18 months. Vancouver-based Angiotech Pharmaceuticals,
Inc., a specialty pharmaceutical company focusing on drug-coated
medical devices and biomaterials, is dedicated to enhancing the
performance of medical devices and biomaterials through the
innovative uses of pharmacotherapeutics. To find out more about
Angiotech Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP),
please visit our website at http://www.angiotech.com/. Statements
contained herein that are not based on historical or current fact,
including without limitation statements containing the words
"anticipates," "believes," "may," "continue," "estimate,"
"expects," "may" and "will" and words of similar import, constitute
"forward-looking statements" within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause the actual results, events or developments
to be materially different from any future results, events or
developments expressed or implied by such forward-looking
statements. Such factors include, among others, the following:
general economic and business conditions, both nationally and in
the regions in which the Company operates; technology changes;
competition; changes in business strategy or development plans; the
ability to attract and retain qualified personnel; existing
governmental regulations and changes in, or the failure to comply
with, governmental regulations; liability and other claims asserted
against the Company; and other factors referenced in the Company's
filings with the United States Securities and Exchange Commission
or the Canadian securities regulators. Given these uncertainties,
readers are cautioned not to place undue reliance on such
forward-looking statements. The Company does not assume the
obligation to update any forward-looking statements. CONTACTS: Todd
Young, Angiotech Pharmaceuticals (Analysts & Investors) (604)
221-7676 ext 6933 Rui Avelar, Angiotech Pharmaceuticals, Inc.
(Analysts) (604) 221-7676 ext 6996 Eric Starkman, Starkman &
Associates (Media) (212) 252-8545 ext 12 DATASOURCE: Angiotech
Pharmaceuticals, Inc. CONTACT: Todd Young, Angiotech
Pharmaceuticals (Analysts & Investors) (604) 221-7676 ext 6933;
Rui Avelar, Angiotech Pharmaceuticals, Inc. (Analysts) (604)
221-7676 ext 6996; Eric Starkman, Starkman & Associates (Media)
(212) 252-8545 ext 12
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