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
FDA Approves Subcutaneous Tecentriq to Treat Multiple Cancers
September 13th 2024Tecentriq Hybreza can be administered over seven minutes, compared with 30 to 60 minutes for IV infusion of Tecentriq. There is no word yet on when Tecentriq Hybreza will be available or what the price will be.
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FDA Warns of Liver Injury with Veozah for Hot Flashes
September 12th 2024The FDA has identified a probable case of serious drug induced liver injury that occurred in a woman in the United States who had received Veozah. The agency is requiring additional liver blood testing after starting therapy.
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