Recent FDA action (through March 2009) related to cetuximab, prasugrel, risperidone, iclaprim, lasofoxifene, ecallantide, laquinimod, C1 inhibitor, SGN-35, and omacetaxine
sBLA withdrawn
• Cetuximab (Erbitux, Lilly/Bristol-Myers Squibb) for the treatment of advanced non-small cell lung cancer (NSCLC)
Complete response
• Iclaprim (Arpida) for the treatment of complicated skin and skin-structure infections
• Lasofoxifene (Pfizer) for the treatment of osteoporosis in postmenopausal women at increased risk of fracture
Recommended for approval
• Prasugrel (Daiichi Sankyo/Lilly) for the treatment of acute coronary syndromes (ACS) in patients managed with percutaneous coronary intervention (PCI)
• Ecallantide (DX-88, Dyax) for the treatment of acute attacks of hereditary angioedema (HAE)
Fast track designation
• Oral laquinimod (Teva/Active Biotech) for the treatment of relapsing-remitting multiple sclerosis (RRMS)
Priority review
• C1 inhibitor (human) (Cinryze, ViroPharma) for the treatment of acute attacks of HAE
Orphan drug designations
• SGN-35 (Seattle Genetics) for the treatment of anaplastic large cell lymphoma
• Omacetaxine (ChemGenex) for the treatment of myelodysplastic syndromes
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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