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See Latest ArticlesImClone Systems and Bristol-Myers Squibb Update Status of First-Line Squamous Cell Carcinoma of the Head and Neck Supplemental Biologics Application for ERBITUX in U.S.
Bristol Myers-Squibb Company, 03/03/09
A wholly-owned subsidiary of Eli Lilly and Company, and Bristol-Myers Squibb Company announced that the companies received a complete response letter from the U.S. Food and Drug Administration for the first-line squamous cell carcinoma of the head and neck supplemental Biologics License Application for ERBITUX. The sBLA was accepted for filing and granted a priority review status in October 2008In its complete response letter, the FDA requested an additional pharmacokinetic study to confirm the comparability of ERBITUX used in the first-line head and neck submission as compared to ERBITUX currently marketed in the United States.
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