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FDA 허가리스트
  • 작성일 2011-12-07 16:31:00
  • 조회수 5812
 
Biologics Approved In 2011
Jangik Ike Lee
U.S. Food and Drug Administration Scientific Investigator[자료제공]

Corifact *
Factor XIII concentrate (human)
CSL Behring
... Factor XIII concentrate made from pooled plasma of healthy donors for routine prophylaxis of bleeding in people with congenital Factor XIII deficiency
2/15/2011

Benlysta
Belimumab
Human Genome Sciences/GlaxoSmithKline
B-lymphocyte stimulator (BLyS)-specific inhibitor for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy
3/9/2011

Yervoy
Ipilimumab
Bristol-Myers Squibb
Cytotoxic T-lymphocyte antigen-4 inhibitor for treatment of unresectable or metastatic melanoma
3/25/2011

LaViv *
Azficel-T
Fibrocell Technologies
Autologous cell therapy for the improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults
6/21/2011

Anascorp *
Centruroides (Scorpion) Immune F(ab’)2 (Equine)
Rare Disease Therapeutics, Inc.
Antivenom for treatment of the clinical signs of scorpion envenomation
8/4/2011

Adcetris
Brentuximab vedotin
Seattle Genetics
CD30-directed antibody-drug conjugate for treatment of Hodgkin lymphoma after failure of autologous stem cell transplantation or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not candidates for ASCT; also for treatment of systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen
8/19/2011
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