Food and Drug Administration
Arthritis Advisory Committee
April 19, 2001
NDA # 21-239 ASLERA™ (prasterone, Genelabs Technologies, Inc.)
Genelabs Technologies Inc.
The statements contained in this document 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.
Presentation ppt html
Backup Slides ppt html
Nonclinical Evaluation of GL701 [prasterone]: NDA 21-239 (Pharmacology/Toxicology), Susan Wilson, D.V.M. , Ph.D. ppt html
Dehydroepiandrosterone and Cortisol Response (Clinical Pharmacology), Abimbola Adebowale, Ph.D. ppt html
Challenges in Study of Drug Effects in Lupus, (Medical), Kent R. Johnson, M.D. ppt html
Statistical Issues in NDA 21-239, Laura Lu, Ph.D. ppt html