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Baxter Receives Tentative FDA Approvals For Ondansetron Injection In Vials And Premix Containers.

May 12, 2015
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. 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. Baxter anticipates receiving

final FDA approval and commencing sales of ondansetron in vial and

premix presentations in zofran birth defects lawyer 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. 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. Premix medications reduce the preparation

steps involved in administering therapies, thereby helping to reduce the

opportunity for errors and contamination. In 2005, U.S. 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. The single and multi dose

vials are also indicated for the prevention of postoperative nausea

and/or vomiting. Efficacy of the 32 mg single dose beyond 24 hours in

these patients has not been established. Ondansetron Injection is

contraindicated for patients known to have hypersensitivity to the drug

and other selective 5-HT3 receptor antagonists. Additionally, in the

premix INTRAVIA plastic container, the concomitant use of apomorphine with ondansetron is contraindicated.



About Baxter



Baxter Healthcare Corporation is the principal U.S. operating

subsidiary of http://csn.cancer.org/node/233524 Baxter International Inc. . Baxter International Inc.,



through its subsidiaries, assists healthcare professionals and their

patients with treatment of complex medical conditions, including cancer,

hemophilia, immune disorders, kidney disease and trauma. 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. 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. 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/



COPYRIGHT 2006 PR Newswire Association LLC



No portion of this article can be reproduced without the express written permission from the copyright holder.

Copyright 2006 Gale, Cengage Learning. All rights reserved.

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