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FDA Grants Soligenix Inc Orphan Drug Designation For OrbeShield For Treatment after Exposure To A Radiological Disaster


Wednesday, 2 Jan 2013 07:15am EST 

Soligenix Inc announced that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted orphan drug designation to OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP) for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster. Oral BDP is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP is the active ingredient in OrbeShield, currently being developed for the treatment of gastrointestinal acute radiation syndrome (GI ARS), the driving component in early mortality following high doses of total body irradiation (TBI). 

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17 Dec 2014