Lupus

New Drug Application Submission to FDA Completed

Published in Women's Health Weekly, October 26th, 2000

Genelabs Technologies, Inc. (GNLB), Redwood City, California, announced it has completed submission of its New Drug Application (NDA) for marketing approval of GL701, its investigational drug for treatment of the chronic autoimmune disease systemic lupus erythematosus (SLE or lupus), to the U.S. Food and Drug Administration (FDA).

In accordance with an agreement reached with the FDA, Genelabs used the rolling NDA process for submitting the NDA, a benefit of Fast Track designation, which was previously granted to GL701 for SLE. The company began the filing process in May 2000 with submission of the complete clinical efficacy and safety data.

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Source: Women's Health Weekly (2000-10-26)

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