Breaking News From Pharma & Bio Ingredients
GE Healthcare recieves priority NDA for new drug
Posted on 2008-06-12 09:59:00
GE Healthcare announced that the U.S. Food and Drug Administration (FDA) has designated for priority review the New Drug Application (NDA) for AdreView. AdreView is a molecular imaging agent for the detection of neuroendocrine tumors in pediatric and adult patients. The FDA also encouraged GE to establish an expanded access program for the agent. An expanded access program is designed to grant physicians limited access to a novel agent prior to FDA approval.
GE Healthcare began development of AdreView in 2004, and the agent was granted orphan-drug designation by FDA in December of 2006. GE's NDA for AdreView was submitted March 20, and accepted by the FDA May 20th. A priority designation is intended for products or indications that address unmet medical needs.
Subscribe via RSS
