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)
Medicare’s Drug Price Negotiations Could Impact Physician Reimbursement
September 19th 2024When CMS begins negotiations for physician-administered drugs under the Inflation Reduction Act, providers, including those whose services are covered by commercial insurance, could see lowered reimbursement.
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