FUJISAWA PLANT CLEARED TO MANUFACTURE ADENOSCAN
Executive Summary
FUJISAWA PLANT CLEARED TO MANUFACTURE ADENOSCAN but approval may be delayed pending the signing of a short-term manufacturing agreement with Medco Research, the holder of the Adenoscan (adenosine) NDA. Medco announced on May 11 that it had "received notification from FDA that Fujisawa's Grand Island [N.Y.] manufacturing facility is now qualified" to produce the cardiovascular stress test agent that will be used as an adjunct to imaging of coronary artery disease and that the company "hopes that an interim manufacturing agreement will be reached with Fujisawa."