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FDA Strengthens Warnings for GlaxoSmithKline (GSK)'s Arzerra and Genentech (RHHBY)'s Rituxan


9/26/2013 7:46:58 AM

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The FDA has approved changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection. The revised labels also will include additional recommendations for screening, monitoring, and managing patients on these drugs to decrease this risk. Both Arzerra and Rituxan are used to treat certain cancers of the blood and lymph system.

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