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News|Articles|May 1, 2007

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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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