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Immunex Enbrel

Executive Summary

Changes to the current vial stopper and potentially to the product delivery configuration are being evaluated following approximately 50 reports "from patients who are experiencing difficulties in penetrating the vial stopper with the needle on the supplied syringe, resulting in bent and otherwise damaged needles," firm says in recent "Dear Doctor" letter. The letter includes a revised video of instructions for preparing and administering Enbrel. The company said the letter was sent to prepare health care professionals in anticipation of Enbrel approval for the new indication of treatment of early stage rheumatoid arthritis (1"The Pink Sheet" April 24, p. 10). The user fee deadline for the sBLA is May 15

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