Ondansetron Injection is
contraindicated for patients known zofran lawsuit success to have hyper...

1. Baxter Receives Tentative FDA Approvals For Ondansetron
Injection In Vials And Premix Containers.
Ondansetron Injection is
contraindicated for patients known zofran lawsuit success to have hypersensitivity to the drug
and other selective 5-HT3 receptor antagonists. Baxter anticipates receiving
final FDA approval and commencing sales of ondansetron in vial and
premix presentations in late December 2006, upon expiration of the
pediatric exclusivity period.
Baxter received tentative abbreviated new drug application (ANDA)
approvals for Ondansetron Injection USP 2 mg/mL packaged in 40 mg/20 mL
multiple-dose vials and 4 mg/2mL single-dose vials. sales of the
vial and premix brand product totaled $585 million.
Ondansetron will be the newest addition to Baxter's existing
portfolio of anesthesia, critical care and oncology products, which
include enhanced packaging, proprietary drugs and other generics.
About Ondansetron
Ondansetron is indicated for the prevention of nausea and vomiting
associated with initial and repeat courses of emetogenic cancer
chemotherapy, including high-dose cisplatin. Efficacy of the 32 mg single dose beyond 24 hours in
these patients has not been established. Baxter International Inc.,
through its subsidiaries, assists healthcare professionals and their
patients with treatment of complex medical conditions, including cancer,

2. hemophilia, immune disorders, kidney disease and trauma. The statements are based on
assumptions
about many important factors, including the following, which could cause
actual results to differ materially from those in the forward-looking
statements: completion of final steps in product development, including
scaling up production, including satisfactory quality and regulatory
work; final FDA approval; the expiration of exclusivity periods; and
other risks identified in the company's most recent filing on Form
10-Q and other SEC filings, all of which are available on the
company's web site. operating
subsidiary of Baxter International Inc. In 2005, U.S. Food and Drug Administration (FDA) for
Ondansetron Injection USP, including the first tentative approval for a
premix version of GlaxoSmithKline's Zofran(R), which is used for
the prevention of nausea and vomiting. . The single and multi dose
vials are also indicated for the prevention of postoperative nausea
and/or vomiting. Premix medications reduce the preparation
steps involved in administering therapies, thereby helping to reduce the
opportunity for errors and contamination. The company does not undertake to update its
forward-looking statements.
CONTACT: Media Contacts, Erin Gardiner, +1-847-948-4210, or
Deborah Spak, +1-847-948-2349, or Investor Contacts, Mary Kay Ladone,
+1-847-948-3371, or Clare Sullivan, +1-847-948-3085, all of Baxter
Healthcare Corporation
Web site: http://www.baxter.com/

3. COPYRIGHT 2006 PR Newswire Association
http://www.medicinenet.com/ondansetron-oral/article.htm LLC
No portion of this article can be reproduced without the express written permission from the
copyright holder.
Copyright 2006 Gale, Cengage Learning.
Final Approval and Launch Expected to Occur Later This Year
Following Expiration of Pediatric Exclusivity Period
DEERFIELD, Ill., June 15 /PRNewswire-FirstCall/ -- Baxter
Healthcare Corporation today announced that it has received tentative
approvals from the U.S. All rights reserved.
. The company
applies its expertise in medical devices, pharmaceuticals and
biotechnology to make a meaningful difference in patients' lives.
For more information about Baxter, please visit http://www.baxter.com/ .
Zofran(R) is a registered trademark of GlaxoSmithKline
This release includes forward-looking statements concerning the
availability of ondansetron. Additionally, in the

4. premix INTRAVIA plastic container, the concomitant use of apomorphine with ondansetron is
contraindicated.
About Baxter
Baxter Healthcare Corporation is the principal U.S. Additionally, the
company received new drug application (NDA) approval for Ondansetron
Injection USP 32 mg/50 mL iso-osmotic sodium chloride solution premix in
INTRAVIA plastic containers