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News Release |
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Baxter Receives FDA Warning Letter on Promotional Materials for ADVATE |
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DEERFIELD, Ill., May 27, 2004 – Baxter Healthcare Corporation said today that it received a warning letter from the Advertising and Promotional Labeling Branch of the U.S. Food and Drug Administration (FDA) regarding certain promotional materials used to support the launch of ADVATE Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF-PFM). The letter relates only to certain promotional literature and is not related to ADVATE’s performance, clinical data, or processing. The concerns outlined by the FDA pertain specifically to the display of appropriate language relating to labeled side effects and supporting data for the statements included in the printed materials.
The company said it has complied with the FDA’s request to stop disseminating the specific promotional materials. In addition, Baxter intends to submit its written response to the FDA that outlines its plan to resolve all issues included in the letter within the specified timeline. The company also confirmed that it is fully committed to working closely with the FDA to address the issues raised and to resolve all outstanding concerns related to promotional literature for ADVATE.
Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter assists health-care 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 www.baxter.com.
Baxter and ADVATE are trademarks of Baxter International Inc. and its affiliates.
This news release contains forward-looking statements that involve risks and uncertainties, including product demand and market acceptance, the effect of economic conditions, actions of regulatory bodies, including the Food and Drug Administration, and other risks detailed in the company's filings with the Securities and Exchange Commission. These forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements.
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| For Additional Information |
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Media Contacts |
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Cindy Resman, (847) 948-2815
Sally Benjamin Young, (847) 948-2304
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Investor Contacts |
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Neville Jeharajah, (847) 948-2875
Mary Kay Ladone, (847) 948-3371
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