Diatide's AcuTect gets priority review
Peptide-based radiopharmaceutical developer Diatide reported last week that the Food and Drug Administration has accepted the company's new drug application (NDA) filing for AcuTect, and has placed the NDA under priority review status. The FDA reserves
Peptide-based radiopharmaceutical developer Diatide reported last week that the Food and Drug Administration has accepted the company's new drug application (NDA) filing for AcuTect, and has placed the NDA under priority review status. The FDA reserves priority review for products that could be a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious or life-threatening disease, according to Londonderry, NH-based Diatide. Receipt of the status means that the review time for AcuTect will most likely be cut in half, with the FDA completing its review in six months. AcuTect is designed for the detection of acute venous thrombosis (SCAN 9/3/97).