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FDA update on brand drugs for October 29, 2009

This is a discussion on FDA update on brand drugs for October 29, 2009 within the New Brand Drug Approvals by Month forum, part of the New Drug Approvals and Pipeline category; Arzerra (ofatumumab) by GlaxoSmithKline Accelerated approval: CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic ...


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Old 10-29-2009, 10:47 AM
chantell.reagan's Avatar
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Default FDA update on brand drugs for October 29, 2009

Arzerra (ofatumumab) by GlaxoSmithKline
Accelerated approval: CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab
•Link to GSK press release 10/09
•Link to prescribing information
•Link to EvaluatePharma 2/09 - Arzerra was predicted to be a blockbuster drug by at least 1 analyst
Sources:

U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA
U.S. Food and Drug Administration. Center for Biologics Evaluation and Research. Available at: CBER

Last edited by chantell.reagan : 10-29-2009 at 11:16 AM.
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