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A discussion of drugs under consideration/review for FDA approval

Key Points

Approvable designations
• Recombinant human growth hormone (Accretropin, Cangene) for the treatment of growth failure in children with growth hormone deficiency and short stature associated with Turner syndrome

• Vildagliptin (Galvus, Novartis) for the oral treatment of patients with type 2 diabetes

Recommendation for approval
• H5N1 bird flu vaccine (Sanofi Pasteur) for the prevention of H5N1 bird flu

Priority review
• Ambrisentan (Gilead) for the treatment of pulmonary arterial hypertension

• Maraviroc (Pfizer) for the treatment of HIV/AIDS

Orphan drug designations
• Cethromycin (Advanced Life Sciences) for the prophylactic treatment of patients exposed to inhalation anthrax

• I-040302 (Kuros Biosurgery) for the treatment of solitary bone cysts

• Recombinant human platelet derived growth factor (BioMimetic Therapeutics) for the treatment of osteonecrosis of the jaw

• Lintuzumab (SGN-33, Seattle Genetics) for the treatment of acute myeloid leukemia

• SGN-35 (Seattle Genetics) for the treatment of Hodgkin's disease

• Maribavir (ViroPharma) for the prevention of cytomegalovirus viremia and disease in at-risk populations

• Tissue repair cells (Aastrom Biosciences) for the treatment of dilated cardiomyopathy

• 17 alpha-hydroxyprogesterone (Gestiva, Adeza) for the prevention of preterm birth in women with a history of preterm delivery

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