Diatide nets milestone for AcuTect
Peptide-based imaging agent developer Diatide has announced that it has received an approvable letter from the Food and Drug Administration for its AcuTect technetium-labeled agent for the imaging of acute venous thrombosis in the lower extremities. The
Peptide-based imaging agent developer Diatide has announced that it has received an approvable letter from the Food and Drug Administration for its AcuTect technetium-labeled agent for the imaging of acute venous thrombosis in the lower extremities. The letter arrived exactly six months following the submission of the new drug application (NDA) to the FDA (SCAN 9/3/97).
The letter indicates that Diatide's NDA will be approved once the company clarifies certain details and formally agrees to specific postapproval requirements, according to the Londonderry, NH-based firm. Diatide expects to begin to co-market AcuTect in the U.S. with its corporate partner Nycomed Amersham immediately following approval of the agent.