Pipeline preview
The latest FDA action (through May 2007) related to armodafinil (Nuvigil), tacrolimus (Prograf), sipuleucel-T (Provenge), Etoricoxib (Arcoxia), AZD-103/ELND005 (Transition), rNAPc2, Satraplatin, and Ganciclovir
Key Points
• Pipeline preview
Approvable designations
Recommendation for approval
Fast-track designations
Priority review
Orphan drug designation
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