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Business Update
Company gets orphan drug designation for Prestara
July 24th, 2005
Genelabs Technologies, Inc., (GNLB) provided an update on the development of Prestara, its investigational drug for lupus. The United States Food and Drug Administration (FDA) has confirmed to the company the indication "prevention of loss of bone mineral density in systemic lupus erythematosus patients on glucocorticoids" qualifies for orphan drug exclusivity under the original orphan drug designation previously received by the company. In October, 2004, Genelabs announced that preliminary results of clinical trial GL02-01 in women with lupus did not show statistical significance for the primary endpoint, absolute change in bone mineral density...
Source: Medical Letter on the CDC & FDA (2005-07-24)
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