Arthritis Advisory Committee

April 19, 2001

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

Briefing Information

Medical, Kent R Johnson MD, FDA   pdf  html

Medical: Appendix   pdf

Statistical Review and Evaluations   pdf   html

Summary of the Pharmacology & Toxicology Review of Prasterone, Susan D Wilson   pdf   html

Summary of BioPharmacology, Abimbola Adebowale PhD   pdf   html

OPDRA Postmarketing Safety Review, Claudia B Karwoski PharmD   pdf   html

Epidemiologic evidence of DHEA in the etiology of neoplasia, Parivash Nourjah PhD   pdf   html

Original Protocol   pdf

Phase III Protocol   pdf

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.

Briefing Information, Genelabs Technologies, Inc.   pdf  html

Appendix 1   pdf

Appendix 2 - 8   pdf   html