Recent FDA action (through May 2009) related to budesonide/formoterol, sertindole, quetiapine, saxagliptin, bevacizumab, dronedarone, and ofatumumab
Complete response
• Budesonide/formoterol (Symbicort, AstraZeneca) for the long-term maintenance treatment of asthma in patients aged 6 to 11 years
• Ecallantide (DX-88, Dyax) for the treatment of acute attacks of hereditary angioedema
• Sertindole (Serdolect, Lundbeck) for the treatment of schizophrenia in certain subpopulations
• Quetiapine extended-release (Seroquel XR, AstraZeneca) for the adjunctive treatment of major depressive disorder (MDD)
• Saxagliptin (Onglyza, Bristol-Myers Squibb/AstraZeneca) for the treatment of adults with type 2 diabetes
• Bevacizumab (Avastin, Genentech) for the treatment of previously treated glioblastoma (accelerated approval recommended)
• Dronedarone (Multaq, Sanofi-Aventis) for the treatment of nonpermanent atrial fibrillation
• Rivaroxaban (Ortho-McNeil) for the prophylaxis of deep vein thrombosis and pulmonary embolism in patients undergoing hip replacement or knee replacement surgery
Not recommended for approval
• Quetiapine extended-release (Seroquel XR, AstraZeneca) for the treatment of generalized anxiety disorder
Fast-track designation
• SGN-35 (Seattle Genetics) for the treatment of Hodgkin lymphoma
Priority review
• Ofatumumab (Arzerra, Genmab) for the treatment of refractory chronic lymphocytic leukemia
• XP12B (Xanodyne) for the treatment of menorrhagia and its accompanying symptoms
Orphan drug designations
• TOL101 (Tolera Therapeutics) for the prophylaxis of acute rejection of solid organ transplantation
• GMI-1070 (GlycoMimetics) for the treatment of vaso-occlusive crisis in patients with sickle cell disease
• Liposomal encapsulation of doxorubicin (ThermoDox, Celsion) for the treatment of hepatocellular carcinoma