Food and Drug Administration
March 5, 2003
Briefing Information
Arava™ (leflunomide)
Disclaimer
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.
Briefing Information Regarding Arava® (leflunomide), Aventis Pharma (PDF)
Table of Contents (PDF)
Section I
Memoradum From the Director of Office of Drug Evaluation V, FDA Dr. Jonca Bull, MD (HTM) (PDF) (Word)
Letter to Committee Members, FDA, Dr. Lee Simon, MD (HTM) (PDF) (Word)
Letter Regarding Rheumatoid Arthritis, FDA, (Dr. Lee Simon, MD (HTM) (PDF) (Word)
Safety Analysis of Leflunomide NDA 20-905, FDA, Dr. Lawrence Goldkind, MD (Word)
A Bi-Cohort Study of the Risks of Leflunomide and Other DMARDs in Rheumatoid Arthritis, FDA (PDF)
MedWatch Reports (PDF)
Section II
Memorandum Regarding NDA 20-905, Arava (leflunomide) Tablets (Superoffice Response to Nov. 7, 2002 Memorandum), Dr. Paul Seligman, MD MPH(HTM) (PDF) (Word)
NDA 20-905 Postmarketing Safety Memorandum; Adverse Drug Experience: Hepatoxicity, Dr Victor Raczkowski, MD MS(PDF)
Postmarketing Safety Review; Severe Hepatoxicity and Liver Failure, Dr. David Graham, MD MPH and Dr. Renan Bonnel, PharmD MPH (PDF)
Post-Marketing Safety Review; Liver Failure (foreign cases), Dr. Lauren Lee, PharmD (PDF)
Section III
Letter From Rheumatology Expert, Dr. Steven Abramson, MD (HTM) (PDF) (Word)
Letters From Hepatology Experts, Dr. A. Leonard Seeff, MD and Dr. B. James Lewis, MD (PDF)
Letter From Epidemiology/Statistics Expert, Dr. Robert Makuch, PhD (HTM) (PDF) (Word)
Section IV
Citizens Petition: Health Research Group (PDF)
Response of Aventis Pharmaceuticals, Inc. to Public Citizen Health Research Group's Petition, Dr. Larry Bell, MD (PDF)
Public Response to Public Citizen Health Research Group's Petition, Dr. Gary Firestein, MD (HTM) (PDF) (Word)
Bibliography (HTM) (PDF) (Word)