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FDA Pipeline preview, May 2009 (budesonide/formoterol, sertindole, quetiapine, saxagliptin, bevacizumab, dronedarone, ofatumumab)


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

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