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Genelabs Requests Meeting With FDA After Aslera "Not-Approvable" Letter

Executive Summary

Genelabs plans to meet with FDA to discuss the NDA for its lupus treatment Aslera (prasterone) following receipt of a "not-approvable" letter June 26.

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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...

Genelabs Prestara “approvable”

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...

Aslera Approval May Be Delayed, Watson Says; Sales Projections Adjusted

Watson expects FDA approval for its lupus treatment Aslera may be delayed following an indecisive advisory committee meeting in April, the company told investors during a May 7 conference call.

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