FDA Panel Votes Down Acusphere Drug
Ryan McBride12/10/08
An FDA advisory panel voted 16-1 (with one panelist abstaining) against recommending approval of Watertown, MA-based Acusphere’s (NASDAQ:ACUS) heart imaging agent, citing abnormally low blood pressure and other reported side effects of perflubutane polymer microspheres (Imagify) as concerns, the AP reports. The imaging agent is intended for use in diagnosing heart disease. The FDA is not obligated to follow the guidance of the advisory panel.
