Astellas Atrial Fibrillation IV Drug Gets US FDA Reviewer Backing (Japan)
This article was originally published in PharmAsia News
Executive SummaryJapan's Astellas Pharma got the backing of a U.S. FDA reviewer in a bid for approval of its intravenous vernakalant drug for treating atrial fibrillation. The reviewer's comments were released by the agency ahead of a Dec.11 meeting by an advisory panel set to decide whether to recommend U.S. approval. Astellas is working with Canada's Cardiome in developing the drug. The FDA staff reviewer said two independent studies confirmed the drug demonstrated efficacy. (Click here for more ) "US FDA Reviewer Backs Astellas-Cardiome Drug" Reuters (U.K.) (12/7/07)
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