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)
FDA Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
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