Angiomax “not approvable” for supplemental indication
Executive Summary
The Medicines Company's Angiomax is "not approvable" for percutaneous coronary intervention with thrombocytopenia or heparin-induced thrombocytopenia and thrombosis syndrome, FDA says. Agency found deficiencies in both the study methods and the analysis of clinical data in the application, TMC says June 3. The company says it will meet with FDA to discuss the issues raised in the letter...
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