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Biotech / Medical : Ligand (LGND) Breakout!
LGND 185.97-0.4%Feb 10 3:59 PM EST

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To: Henry Niman who wrote (7308)9/23/1997 5:07:00 PM
From: squetch   of 32384
 
Henry, Paxene is IVAX/NPRO version of paclitaxel. I don't understand the Orphan Drug Act. Below is the "clearest" wording of this status.

"Once an orphan drug is approved,exclusivity gives sponsors legal protection against introduction of an identical competing product for seven years." What is meaning of "identical competing product"? That says generic to me. Paxene really a generic form of paclitaxel. So the act protects against generics?

fda.gov

Stan
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