FDA pipeline preview, July 2007

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The latest FDA action (through July 2007) related to tramadol (Labopharm), SPD465 (Shire), continuous erythropoiesis receptor activator (Roche), fosaprepitant (Merck), ACAM2000 smallpox vaccine (Acambis), repository corticotropin injection (Questcor), rimonabant (Sanofi-Aventis), tamibarotene (Innovive), mycophenolate (Aspreva), romidepsin (Gloucester), aripiprazole (Otsuka/Bristol-Myers Squibb), AMT 011 (Amsterdam Molecular Therapeutics), aminolevulinic acid (Dusa), cyclosporine A (Novagali), and ARD-07 (Ardana)

Key Points

• Pipeline preview

Approvable designations

Recommendation for approval

Not recommended for approval

Fast-track designations

Priority review

Orphan drug designations

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