FDA staff: Medicines Co.'s Cangrelor drug should not be approved
Feb 10 (Reuters) - An intravenous blood clot preventer developed by The Medicines Company should not be approved, according to an initial review by the U.S. Food and Drug Administration, which said data did not show that the product was as good as or superior to a rival drug.
The review, posted on the FDA's website on Monday, comes two days ahead of a meeting of outside experts who will recommend whether the drug should be approved. The FDA is not required to follow the recommendations of its advisors but typically does so.
The drug, Cangrelor, is designed to prevent blood clots during heart artery-clearing angioplasty and stenting procedures. The FDA review said the company should conduct a new trial before the drug is considered for approval.
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