Wilate® – von Willebrand factor/coagulation factor VIII complex (human) – approved – 12/4/2009
Replacement therapy for von Willebrand disease.
Kalbitor® – ecallantide – approved – 12/1/2009
For the treatment of acute attacks of hereditary angioedema in patients 16 years of age and older.
Agriful® – influenza virus vaccine – approved – 11/27/2009
For immunization against influenza virus subtypes A and B in adults.
Istodax® – romidepsin – approved – 11/5/2009
For the treatment of cutaneous T-cell lymphoma (CTCL).
Arzerra™ – ofatumumab – approved – 10/26/2009
For the treatment of refractory chronic lymphocytic leukemia (CLL).
Votrient™ – pazopanib – approved – 10/19/2009
For the treatment of advanced renal cell carcinoma.
Cervarix® – human papillomavirus vaccine (types 16 and 18), recombinant – approved – 10/16/2009
For the prevention of cervical neoplasia and cervical cancer associated with human papillomavirus.
Berinert® – C1 esterase inhibitor (human) – approved – 10/9/2009
For the treatment of acute abdominal and facial attacks of hereditary angioedema in adults and adolescents.
Stelara™ – ustekinumab – approved – 9/25/2009
For the treatment of moderate to severe plaque psoriasis in adults.
Folotyn™ – pralatrexate injection – approved – 9/24/2009
For the treatment of relapsed or refractory peripheral T-cell lymphoma.
Gammaplex® – immune globulin intravenous – approved – 9/17/2009
For the treatment of primary immunodeficiency diseases.
Vibativ™ – telavancin – approved – 9/11/2009
For the treatment of complicated skin and skin structure infections in adults.
Bepreve™ – bepotastine besilate ophthalmic solution – approved – 9/8/2009
For the treatment of ocular itching associated with allergic conjunctivitis in patients two years of age and older.
Sabril® – vigabatrin – approved – 8/21/2009
For the treatment of infantile spasms and complex partial seizures in adults.
Hiberix® – haemophilus B conjugate vaccine (tetanus toxoid conjugate) – approved – 8/19/2009
For booster immunization for Haemophilus influenzae type B in children age 15 months through 4 years.
Saphris® – asenapine – approved – 8/14/2009
For the treatment of adults with schizophrenia and adults with bipolar I disease.
Livalo® – pitavastatin – approved 8/3/2009
For the improvement of blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels.
Onglyza™ – saxagliptin – approved 7/31/2009
For the treatment of Type 2 diabetes in adults.
Effient™ – prasugrel hydorchloride – approved 7/10/2009
For reducing the risk of blood clots from forming during angioplasty.
Multaq® – dronedarone – approved 7/1/2009
For use in patients with a history of atrial fibrillation or atrial flutter; to be used in patients whose hearts have returned to normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heart beat.
Ilaris® – canakinumab – approved 6/17/2009
For the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS).
Besivance™ – besifloxacin – approved 5/28/2009
For the treatment of bacterial conjunctivitis.
Samsca™ – tolvaptan – approved 5/19/2009
For treatment of hyponatremia (low concentration of sodium in the blood) associated with congestive heart failure, liver cirrhosis, and the syndrome of inappropriate antidiuretic
hormone secretion.
Fanapt™ – iloperidone – approved 5/6/2009
For treatment of adults with schizophrenia.
Dysport® – abobotulinumtoxinA – approved 4/30/2009
For the treatment of cervical dystonia; to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults younger than 65 years of age for a short period of time (temporary).
Simponi™ – golimumab – approved 4/24/2009
For the treatment of adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.
Ulesfia™ – benzyl alcohol – approved 4/9/2009
For the treatment of head lice.
Coartem® – artemether lumefantrine – approved 4/7/2009
For the treatment of acute, uncomplicated malaria infections in adults and children weighing at least 5kg.
Afinitor® – everolimus – approved 3/30/2009
For the treatment of advanced kidney cancer in patients whose cancer has progressed after other treatments.
Ixiaro® – encephalitis vaccine approved 3/30/2009
Vaccine to prevent Japanese encephalitis injection.
Uloric® – febuxostat – approved 2/13/2009
For the management of gout.
ATryn® – approved 2/6/2009
For the prevention of blood clots in patients with hereditary antithrombin deficiency.
RiaSTAP™ – fibrinogrn concentrate– approved 1/16/2009
For the treatment of bleeding in patients with a rare genetic defect known as congenital fibrinogen deficiency.
Savella® – milnacipran hydrochloride – approved 1/14/2009
For the management of fibromyalgia.
