Baxter Healthcare Corporation, the principal US operating subsidiary of Baxter International Inc. said that it received a warning letter from the Advertising and Promotional Labeling Branch of the US 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 and Advate are trademarks of Baxter International Inc. and its affiliates.