Food and Drug Administration

Arthritis Advisory Committee

August 7, 1998


Sponsor Presentation


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Arava™ Leflunomide, Hoechst Marion Roussel, Inc.   pdf

FDA Presentation

Medical:  Kent Johnson, MD, FDA   pdf

Statistics:  Issues and Analyses on Missing X-ray Scores, Laura Lu, PhD, FDA   pdf

Pharmacology: Asoke Mukherjee, PhD, FDA   pdf

Pharmacokinetic Issues of Leflunomide, Veneeta Tandon, PhD, FDA   pdf