Imre
This article was originally published in The Gray Sheet
Executive Summary
Has received "full FDA approval" of its new manufacturing facility, allowing the firm to conduct unrestricted shipments of its Prosorba column, which is approved for treatment of ideopathic thrombocytopenic purpura (ITP). On Dec. 28, 1992, FDA granted the firm permission to ship the device for emergency ITP treatments. The emergency shipments followed an earlier suspension of shipments because of delay in obtaining approval for the new facility ("The Gray Sheet" Dec. 14, 1992, In Brief).