FDA orphan drug designations: Zactima, Surfaxin, IL-21
The FDA approved orphan drug designation for lucinactant (Surfaxin) on October 28, 2005, for the treatment of bronchopulmonary dysplasia (BPD) in premature infants. Discovery Labs, manufacturer of Surfaxin, is currently conducting a Phase II trial to determine the safey and tolerability of lucinactant as a therapeutic approach for prevention of BPD.
The FDA approved orphan drug designation for interleukin 21 (IL-21) on October 5, 2005, for the treatment of advanced or aggressive melanoma. Produced by ZymoGenetics, IL-21 is being evaluated in Phase Ib clinical trials of melanoma and renal cell carcinoma.


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