Food and Drug Administration

Arthritis Advisory Committee

Slides

April 19, 2001

NDA # 21-239 ASLERA™ (prasterone, Genelabs Technologies, Inc.)

Genelabs Technologies Inc.

Disclaimer

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

FDA Presentation

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