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