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Aeolus Pharmaceuticals Inc receives orphan drug designation for AEOL 10150 From U.S. FDA


Thursday, 23 Jan 2014 10:52am EST 

Aeolus Pharmaceuticals Inc:Says it has received notice from the Office of Orphan Products Development at the U.S. Food & Drug Administration (FDA) granting Orphan Drug Designation for AEOL 10150.Says for use in patients exposed to radiation following a nuclear accident or detonation in order to treat or mitigate acute radiation syndrome.Says Orphan Drug Designation entitles the sponsor to a seven-year marketing exclusivity period, clinical protocol assistance with the FDA, as well as federal grants and tax credits.Says Aeolus is developing AEOL 10150 as a treatment for the pulmonary and delayed effects of acute radiation exposure under a five-year contract with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services.Says AEOL 10150 is a broad-spectrum catalytic antioxidant specifically designed to neutralize reactive oxygen and nitrogen species. 

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21 Jul 2014