Recent FDA action (through June 2011) related to oxycodone, aflibercept opthalmic solution, icatibant, eculizumab, asimadoline, anthrax vaccine, SBC-102 enzyme replacement therapy, ciprofloxacin, mitosol, MORAb-004 and MORAb-066, levofloxacin.
• Oxycodone (Remoxy, Pfizer and Pain Therapeutics) extended-release capsules CII for the relief of moderate-to-severe pain requiring continuous, around-the-clock opioid treatment.
Recommended for approval
• Icatibant (Firazyr, Shire) for the treatment of acute attacks of hereditary angioedema in patients aged 18 years and older.
• Eculizumab (Soliris, Alexion) for the treatment of atypical hemolytic uremic syndrome.
• Asimadoline (Tioga Pharmaceuticals) for the treatment of irritable bowel syndrome.
• Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant (NuThrax, Emergent BioSolutions) for the treatment of anthrax.
• SBC-102 enzyme replacement therapy (Synageva BioPharma) for the treatment of lysosomal acid lipase deficiency.
Orphan drug designations
• Ciprofloxacin for inhalation (Aradigm) for the management of bronchiectasis.
• Mitosol (Mobius Therapeutics) for the prevention of corneal haze following surface ablation laser keratectomy.
• MORAb-004 and MORAb-066 (Morphotek) for the treatment of soft-tissue sarcoma and pancreatic cancer, respectively.