Indications -- Lupus/Nephritis Message Board

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Biotech / Medical : Indications -- Lupus/Nephritis

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To: keokalani'nui who wrote (31)	6/27/2001 10:57:53 AM
From: keokalani'nui	Read Replies (1) of 95

FDA Notifies Genelabs That Aslera(TM) NDA is Not Approvable Genelabs Will Work with the FDA to Address Issues 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.

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