Protalix looks to February for US FDA decision on Gaucher's drug
This article was originally published in Scrip
Executive Summary
The US FDA has accepted Protalix BioTherapeutics’ resubmission for its new drug application for its experimental Gaucher's disease drug taliglucerase alfa, designating it as a Class 2, or six-month review, setting the new Prescription Drug User Fee Act (PDUFA) action date as 1 February 2012, the company said in a 17 August statement.