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Genelabs Prestara “approvable”

Executive Summary

Genelabs plans to meet with FDA to discuss additional study for lupus treatment Prestara (prasterone) (formerly Aslera), following receipt of "approvable" letter Aug. 28. Approval is contingent upon study confirming positive effect on bone mineral density in women with mild to moderate systemic lupus erythematosus while on low-dose glucocorticoids. The product was deemed "not approvable" June 26, 2001 (1"The Pink Sheet" July 2, 2001, p. 16). Prestara will be marketed by Watson...

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