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This article was originally published in Pharmaceutical Approvals Monthly
Genentech and Xoma anticipate submitting a Xanelim (efalizumab) BLA for psoriasis treatment in summer 2002. The companies had predicted a year-end or first quarter 2002 submission, but FDA requested a pharmacokinetic study to confirm equivalence between the drug formulation used in clinical trials and that planned for large-scale manufacture
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