Durasphere Post-Approval Studies Should Focus On Subgroups - FDA Panel
This article was originally published in The Gray Sheet
Advanced UroScience is anticipating a worldwide launch of the injectable bulking agent Durasphere sometime in the fourth quarter, following an approvable recommendation from FDA's Gastroenterology and Urology Devices Panel at its July 29 meeting in Rockville, Maryland.
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Advanced UroScience's post-approval study of its Durasphere bulking agent for treatment of female stress urinary incontinence due to intrinsic sphincter deficiency will focus on evaluating the durability of the product, the company reports.
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