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FDA Delays Approval of Clot-Busting Drug

by Kathy Jones on  June 26, 2012 at 11:16 PM Drug News   - G J E 4
The US Food and Drug Administration has once again delayed the approval of an experimental drug developed by Pfizer and Bristol-Myers Squibb, stating that it needs more information of the study which looked into the effectiveness of the drug.
 FDA Delays Approval of Clot-Busting Drug

A number of analysts believe that the drug, known as Eliquis, is better than the two new clot-preventing drugs currently in the market. However the FDA said that it needs more data regarding "data management and verification" of the study known as ARISTOTLE which looked into the effectiveness of Eliquis preventing strokes in patients with an irregular heartbeat called atrial fibrillation.

While analysts predict that it will take at least a year for FDA to once again decide on whether to approve the drug or not, a spokeswoman for Bristol-Myers Squibb expressed hope that the review process could be completed sooner. "We are already working with the agency, and we are hopeful that the review of our submission can be completed within a shorter timeframe", she said.

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