Salvat expects the FDA to classify the complete response as a class 2 resubmission, under which the FDA will seek to complete its review of the resubmission within 180 days from the time of resubmission. Salvat believes that the response submitted to the FDA fully addresses the agency request.
Salvat is currently evaluating potential commercial partners in the US to licensing out Cetraxal and expects to launch it during the second quarter of 2009, subject to FDA approval.
The new drug application for Cetraxal seeks marketing approval for the treatment of acute otitis externa in pediatric and adult patients.