Rhophylac warning letter
Executive Summary
ZLB Behring is revising Rhophylac web site after receiving 1warning letter from FDA biologics ad branch. "Main parts" of 2www.rhophylacusa.com, a sales aid and a patient Q&A "make claims of safety and effectiveness, but fail to provide risk information, including the contraindications, warnings, precautions, and adverse reaction information," the Sept. 14 warning letter states. FDA said simply referencing labeling in the promotions is "not sufficient." ZLB submitted a response to the letter Sept. 23. Rhophylac was approved Feb. 12 (3"The Pink Sheet" Feb. 23, 2004, In Brief)...