Published in Medical Letter on the CDC and FDA, July 24th, 2005
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...
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