FDA Pipeline preview, November 2008 (aztreonam lysine, fentanyl buccal, tocilizumab, everolimus, ENB-0040, artemether/lumefantrine)
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
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.
Read More
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.
Read More
