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Friday, February 27, 2009

New biologics approved by the US FDA's Center for Drug Evaluation and Research in 2008

FROM THE FOLLOWING ARTICLE:

2008 FDA drug approvals

Bethan Hughes

Nature Reviews Drug Discovery 893-96 (February 2009)

doi:10.1038/nrd2813

Generic name (Trade name)Company*Indication(URL of label information if available)PropertiesDate
Rilonacept (Arcalyst)RegeneronCryopyrin-associated periodic syndromes including familial cold autoinflammatory syndrome and Muckle–Wells syndrome (http://www.fda.gov/cder/foi/label/2008/125249lbl.pdf)Interleukin-1 blocker27 Feb (P, O)
Certolizumab pegol (Cimzia)UCBCrohn's disease (http://www.fda.gov/cder/foi/label/2008/125160s000lbl.pdf)Tumour necrosis factor blocker22 Apr (S)
Romiplostim (Nplate)AmgenThrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (http://www.fda.gov/cder/foi/label/2008/125268lbl.pdf)Thrombopoietin receptor agonist22 Aug (P, O)
*The company that submitted the original biologic license application to the US FDA. O, FDA orphan designation; P, FDA priority review; S, FDA standard review.

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