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FDA to decide by March 17 on Pfizer/Bristol blood thinner
Sept 26 |
Sept 26 (Reuters) - U.S. health regulators set a date of March 17 to decide whether to approve a closely watched blood clot preventer developed by Bristol-Myers Squibb Co and Pfizer Inc for use in patients suffering from atrial fibrillation, the companies said on Wednesday.
The U.S. Food and Drug Administration in June declined to approve the drug, Eliquis, and asked the companies to provide more information on a pivotal clinical trial of the medicine, which is designed to reduce the risk of stroke caused by blood clots in heart patients.
Wall Street and the medical community widely expect approval of Eliquis, known chemically as apixaban, and see it becoming a major in an estimated $10 billion market for new alternatives to the decades old blood thinner warfarin.
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