Ferndale Pharma Group, Echo Therapeutics partner, has received comments from the US Food and Drug Administration (FDA) on the 510(k) submission of the Prelude SkinPrep System.
The Prelude SkinPrep System is a transdermal drug delivery system designed as a platform technology for enhanced skin permeation for delivery of topical pharmaceuticals
Echo anticipates that the comments will be addressed quickly and that the planned commercial launch date for the product will remain on track, pending FDA clearance.
As a result of the feedback from the FDA, the company is accelerating the final Prelude manufacturing validation and scale-up in order to prepare for commercial launch.
Echo Therapeutics chairman and CEO Patrick Mooney said their primary focus is the completion of manufacturing and final product specifications in order to garner FDA clearance of Prelude.
"We believe that the FDA’s comments will allow us to accelerate our manufacturing scale-up for product validation and product launch in 3Q2011," Mooney said.
"Additionally, we believe that FDA clearance of Prelude will clear the way for completing additional strategic partner licensing arrangements this year."