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Biotech / Medical : genelabs(gnlb) -- Ignore unavailable to you. Want to Upgrade?

To: Toni Wheeler who wrote (227)	6/27/2001 4:59:41 AM
From: nigel bates	Read Replies (2) \| Respond to of 233

REDWOOD CITY, Calif., and CORONA, Calif., June 26 /PRNewswire/ -- Genelabs Technologies, Inc. (Nasdaq: GNLB - news) and Watson Pharmaceuticals, Inc. (NYSE: WPI - news) announced today that the U.S. Food and Drug Administration (FDA) has issued a ``not approvable'' letter with respect to Genelabs' New Drug Application (NDA) for Aslera(TM) (prasterone) for the treatment of women with mild to moderate systemic lupus erythematosus (SLE or lupus). The agency cited various issues in the letter, primarily relating to the interpretation of efficacy and safety data submitted in the NDA.* (Photo: NewsCom: newscom.com ) Genelabs is committed to working with the FDA to address the deficiencies cited and expects to meet with the FDA promptly to clarify the issues raised and the steps required to be taken before the NDA may be approved. The companies stated that they intend to continue the efforts toward approval of this product because both Genelabs and Watson believe in its potential to improve the lives of women suffering from the debilitating effects of lupus...