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®, 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 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.
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.
Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX - News). 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® 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.
Source: Baxter Healthcare Corporation