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news.The US Food and Drug Administration (FDA) has given orphan drug designation to Tengion's Neo-Urinary Conduit.
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The biotechnology firm’s Neo-Urinary Conduit is indicated as a treatment for bladder dysfunction requiring incontinent urinary diversion.
Orphan drug designation offers Tengion seven years of US marketing exclusivity for the Neo-Urinary Conduit if and when it receives regulatory approval.
Tengion chief medical officer Sunita Sheth said this designation is another important step in advancing the development of the Neo-Urinary Conduit, their lead clinical product candidate, currently being studied in patients with bladder cancer.