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GSK, Genmab biologic gets PDUFA date of April 19, 2014
December 18, 2013
By: Gil Roth
President, Pharma & Biopharma Outsourcing Association
GlaxoSmithKline and Genmab have received Priority Review designation from the FDA for the sBLA for the use of Arzerra (ofatumumab) in combination with an alkylator-based therapy, to be used for treatment of chronic lymphocytic leukemia (CLL) patients who have not received prior treatment and are inappropriate for fludarabine-based therapy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of April 19, 2014 for the sBLA for Arzerra. Ofatumumab is not approved or licensed ...
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