Diatide NeoTect
Executive Summary
Technetium Tc-99m depreotide injection receives "approvable" letter Dec. 17 for imaging of suspected malignant lung tumors. FDA requests clarification and additional analysis of safety and efficacy data, as well as additional chemistry assays as part of Phase IV commitments. The product had priority review status and the "approvable" letter was sent six months after the NDA submission, Londonderry, N.H.-based Diatide reports