Thursday said its U.S. health care unit received a warning letter from the Food and Drug Administration about promotional materials used in the launch of its Advate treatment for hemophiliacs.
The company said the letter relates "only to certain promotional literature and is not related to Advate's performance, clinical data or processing." In particular, the FDA letter addresses the display of language relating to labeled side effects and supporting data for the statements included in the printed materials.
The Deerfield, Ill.-based medical products company said it has complied with the FDA's request to stop disseminating the materials, and intends to submit a written response outlining plans to resolve all issues included in the letter.
The letter was sent to Baxter Healthcare.