GE Healthcare yesterday announced that the U.S. Food and Drug Administration has designated for priority review the New Drug Application (NDA) for AdreView, a molecular imaging agent for the detection of neuroendocrine tumors in pediatric and adult patients.

According to GE, the FDA also encouraged the company to establish an expanded access program that would grant physicians limited access to the novel agent prior to approval.

A priority designation is intended for products or indications that address unmet medical needs.

GE Healthcare began development of AdreView in 2004, and FDA gave it orphan-drug designation in December of 2006. GE’s NDA for AdreView was submitted March 20 and accepted by the FDA on May 20.