Astellas Atrial Fibrillation IV Drug Gets US FDA Reviewer Backing (Japan)
This article was originally published in PharmAsia News
Executive Summary
Japan'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)
You may also be interested in...
Generic Or Innovator? Sandoz Sues CMS Over Potential Change In Rebate Classification
Sandoz argued against paying higher rebates for two of its drugs via the Centers for Medicare and Medicaid Services’ Medicaid drug rebate program in a US court six years after the suggestion was first made.
Ultrahuman Expands Wearable Medtech Production Into US After $35M Funding Round
Firm operating in London, India and United Arab Emirates says its “Ultra Factory” will open in Indiana within the next six months with end-to-end production based on its operational facility in India.
Cochlear’s Osia System Receives Expanded FDA Clearance For Use In Younger Children
Kids ages 5 and up now can benefit from Cochlear’s Osia implant and sound processor, indicated for hearing loss, mixed hearing loss and single-sided sensorineural deafness.