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Pluristem Therapeutics Inc Receives FDA Orphan Drug Status Designation For Treatment Of Aplastic Anemia


Thursday, 21 Feb 2013 02:45am EST 

Pluristem Therapeutics Inc announced that the U.S. Food and Drug Administration (FDA) has designated Pluristem's PLacental eXpanded (PLX) cells orphan drug status for the treatment of aplastic anemia. Orphan drug designation qualifies a company for several benefits under the Orphan Drug Act of 1983 (ODA), as amended. These benefits include a seven-year period of orphan drug exclusivity upon product approval, a tax credit for certain clinical testing expenses for the orphan drug, written guidance on the non-clinical and clinical studies needed to obtain marketing approval of an orphan drug, and orphan drug grants. This is Pluristem's second orphan drug designation from the FDA. The Company also received orphan drug status from the FDA for PLX cells for the treatment of Buerger's disease in August of 2011. 

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11:45am EDT