Recent FDA action (through January 2009) related to ceftobiprole, oblimersen, motavizumab, rufinamide, febuxostat, telavancin, and ecallantide
Complete response
• Ceftobiprole (Johnson & Johnson) for the treatment of complicated skin and skin-structure infections, including diabetic foot infections
•Oblimersen (Genasense, Genta) in combination with chemotherapy for the treatment of chronic lymphocytic leukemia
•Rufinamide (Banzel, Eisai) as adjunctive treatment for partial-onset seizures with and without secondary generalization in patients aged ≥12 years
Recommendations for approval
•Febuxostat (Takeda) for the treatment of hyperuricemia in patients with gout
•Telavancin (Theravance) for the treatment of complicated skin and skin-structure infections caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA)
Priority review
•Ecallantide (Dyax) for the treatment of acute attacks of hereditary angioedema (HAE)