GE gets FDA priority review for imaging agent
| Company News - GE Healthcare |
GE Healthcare, a unit of General Electric Corp, said on Thursday US health regulators granted it priority review on its application for AdreView, a molecular imaging agent for the detection of neuroendocrine tumors in children and adult patients.
The company said the US Food and Drug Administration 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, a manufacturer of medical imaging systems, began development of AdreView in 2004, and the agent was granted orphan-drug designation by the FDA in December 2006.
GE's new drug application for AdreView was submitted March 20 and accepted by the FDA May 20. A priority designation is intended for products or indications that address unmet medical needs.
(Reporting by Debra Sherman; Editing by Brian Moss)






