Summary of the US FDA approval of belatacept

American Journal of Transplantation

Volumn 12, Issue 3, 2012, Pages 554-562

  Archdeacon, P ^a   Dixon, C ^a   Belen, O ^a   Albrecht, R ^a   Meyer, J ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Belatacept; clinical trials; efficacy; endpoints; safety

Indexed keywords

BELATACEPT; CYCLOSPORIN A;

ACUTE GRAFT REJECTION; ARTICLE; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; KIDNEY GRAFT; KIDNEY TRANSPLANTATION; LYMPHOPROLIFERATIVE DISEASE; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; PROPHYLAXIS; RISK BENEFIT ANALYSIS; TUBERCULOSIS; UNITED STATES;

ADULT; CONSUMER PRODUCT SAFETY; DRUG APPROVAL; GRAFT REJECTION; HUMANS; IMMUNOCONJUGATES; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84863393430     PISSN: 16006135     EISSN: 16006143     Source Type: Journal    
DOI: 10.1111/j.1600-6143.2011.03976.x     Document Type: Article

References (18)

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6. 21 CFR 314.126
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