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Bristol submits muraglitazar, abatacept to FDA

Executive Summary

Bristol-Myers Squibb submits muraglitazar NDA for treatment of type-2 diabetes to FDA. Bristol and Merck will co-market the product (1"The Pink Sheet" May 3, 2004, p. 15). Bristol also submitted the non-clinical and clinical sections of the abatacept BLA for rheumatoid arthritis under FDA's "continuous marketing application" program. The remaining sections will be completed in early 2005, the company said. The firm had said the full application for abatacept would be submitted before the end of 2004 and a supplemental BLA would follow with manufacturing changes (2"The Pink Sheet" Sept. 20, 2004, p. 29)...
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