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Centocor’s ustekinumab delayed

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA pushes Centocor's ustekinumab PDUFA date to December, granting the agency more time to review BLA amendments, the firm announces Aug. 8. Ustekinumab was unanimously recommended by an FDA advisory committee in June for approval for moderate to severe psoriasis, but the panel asked the J&J unit for long-term studies to evaluate cancer risk. The drug, which is aiming for a dosing advantage with a four injections per year regimen, was originally slated for an agency decision in September (1Pharmaceutical Approvals Monthly July 2008, p. 3). According to Centocor, FDA is not seeking additional clinical trials for ustekinumab

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