FDA Pipeline preview, January 2009 (ceftobiprole, oblimersen, motavizumab, rufinamide, febuxostat, telavancin, ecallantide)
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)
Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary
March 13th 2025Lumicera Health Services, Navitus’ specialty pharmacy, has made a deal with Teva to offer an unbranded biosimilar that they estimate will save $112,000 and $336,000 per patient per year. Navitus will remove Stelara from formulary on July 1, 2025.
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FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
March 6th 2025Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
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