Reuters: Regulatory News: Bristol/Pfizer clot preventer delayed in U.S.

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Bristol/Pfizer clot preventer delayed in U.S. Jun 25th 2012, 11:45 June 25 | Mon Jun 25, 2012 7:45am EDT June 25 (Reuters) - A closely watched blood clot preventer from Bristol-Myers Squibb Co and Pfizer Inc has failed to win approval from U.S. health regulators, the companies said on Monday. Investors have been awaiting a decision on the drug, Eliquis, by the Food and Drug Administration by the end of the month. The FDA notification did not require the companies to complete any new studies, the companies said, which could mean only a short delay before the drug wins approval. Rather, the agency wants more information on data management and verification from a key clinical trial supporting the medicine.

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