Recent FDA action (through November 2008) related to aztreonam lysine, fentanyl buccal, tocilizumab, everolimus, ENB-0040, and artemether/lumefantrine
Complete responses
• Aztreonam lysine for inhalation (Gilead) for the treatment of Pseudomonas aeruginosa infection in patients with cystic fibrosis (CF)
• Fentanyl buccal tablet (Fentora, Cephalon) for the treatment of noncancer breakthrough pain in opioid-tolerant patients
• Tocilizumab (Actemra, Roche) for the treatment of moderate-to-severe rheumatoid arthritis (RA)
Priority review
• Recombinant form of human antithrombin (ATryn, GTC) for the prophylactic treatment of deep vein thrombosis (DVT) and other thromboembolisms in patients with hereditary antithrombin deficiency who are undergoing high-risk surgical or childbirth procedures
• Artemether/lumefantrine (Coartem, Novartis) for the treatment of malaria
• Everolimus (Novartis) for the treatment of advanced kidney cancer after failure of standard treatment
Orphan drug designation
• ENB-0040 (Enobia) for the treatment of hypophosphatasia
FDA and EMA Accepts Applications for New Nusinersen Regimen
January 23rd 2025An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower FDA-approved dosage.
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