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Centocor Remicade Black Box MD Visits Will Be 85% Complete By Aug. 31

Executive Summary

Centocor sales representatives will visit 85% of targeted Remicade prescribers by the end of August to inform them of a new black box warning added to labeling for the rheumatoid arthritis therapy, Exec Director-Medical Affairs Tom Schaible, PhD, told the FDA Arthritis Advisory Committee.

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Safety of tumor necrosis factor inhibitors and a possible link to lymphoma will be discussed by FDA's Arthritis Drugs Advisory Committee March 4. The committee will receive safety updates on all three marketed TNF inhibitors - Amgen's Enbrel, Centocor's Remicade and Abbott's Humira. The committee's TNF inhibitor safety review in August 2001 focused on the risk of immune disorders (1"The Pink Sheet" Aug. 20, 2001, p. 7)...

TNF inhibitor safety

Safety of tumor necrosis factor inhibitors and a possible link to lymphoma will be discussed by FDA's Arthritis Drugs Advisory Committee March 4. The committee will receive safety updates on all three marketed TNF inhibitors - Amgen's Enbrel, Centocor's Remicade and Abbott's Humira. The committee's TNF inhibitor safety review in August 2001 focused on the risk of immune disorders (1"The Pink Sheet" Aug. 20, 2001, p. 7)...

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Abbott is focusing on the need for a regular supply of an anti-TNF agent that can be dosed without methotrexate as a justification for requiring a faster review of D2E7 at FDA

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