Brand Name | Generic Name | FDA Approval | Indication | Administration | Exclusion Reason |
---|---|---|---|---|---|
Lucentis | Ranibizumab | 6/30/2006 | Macular degeneration | Intravitreal | Part B |
Soliris | Eculizumab | 3/16/2007 | Paroxysmal nocturnal hemoglobinuria | IV infusion | Part B |
Entereg | Alvimopan | 5/20/2008 | Aids recovery of bowel resection surgery | PO post-op | Part A |
Cleviprex | Clevidipine | 8/1/2008 | Blood pressure control when oral therapy not feasible | IV infusion | Part B |
Nplate | Romiplostim | 8/22/2008 | Idiopathic (immune) thrombocytopenic purpura | Subcutaneous | Part B |
Lusedra | Fospropofol | 12/12/2008 | Sedation | IV infusion | Part B |
Kalbitor | Ecallantide | 12/1/2009 | Hereditary angioedema | Subcutaneous | Part B |
Xiaflex | Collagenase clostridium histolyticum | 2/2/2010 | Dupuytren’s disease | Injection | Part A/B |
Asclera | Polidocanol | 3/30/2010 | Varicose veins | IV injection | Part A/B |
Krystexxa | Pegloticase | 9/14/2010 | Hyperuricemia/gout | IV infusion | Part B |
Adcetris | Brentuximab vedotin | 8/19/2011 | Hodgkin lymphoma (third-line agent) | IV infusion | Part B |
Eylea | Aflibercept | 11/18/2011 | Macular degeneration | Intravitreal | Part B |
Kyprolis | Carfilzomib | 7/20/2012 | Multiple myeloma (third-line agent) | IV infusion | Part B |
Jetrea | Ocriplasmin | 10/17/2012 | Vitreomacular adhesion | Intravitreal | Part B |
FDA = U.S. Food and Drug Administration; IV = intravenous; PO = per oral.