New detective agents await FDA approval
The U.S. Food and Drug Administration has told Pharmacyclics, in Sunnyvale, CA, that its Gadolite Oral Suspension product, a magnetic resonance imaging contrast agent, is approvable subject to the submission of additional information and final product labeling.
Glaxo Wellcome is the worldwide manufacturer of Gadolite, which is marketed in the United States by E-Z-EM Ltd.
Immunomedics, in Morris Plains, NJ, has submitted a biologies license application to the FDA for Leukoscan, a radio-labeled monoclonal antibody fragment. It aids in detection of infectious diseases, such as osteomyelitis in long bones and patients with diabetics foot ulcers, and in patients with right lower quadrant diseases such as acute atypical appendicitis.
Neoprobe Corp., in, Dublin, Ohio, has also sought a biologic license for RIGScan CR49, a 125I-labeled monoclonal antibody, for the detection of cancer of the colon and rectum.