Nycomed files MAA for Diatide's AcuTect
Peptide imaging agent developer Diatide of Londonderry, NH, reported last month that its marketing partner, Nycomed Amersham, has submitted Diatide's AcuTect product for regulatory review by European authorities. Nycomed, of Buckinghamshire, U.K.,
Peptide imaging agent developer Diatide of Londonderry, NH, reported last month that its marketing partner, Nycomed Amersham, has submitted Diatide's AcuTect product for regulatory review by European authorities. Nycomed, of Buckinghamshire, U.K., submitted a marketing approval application (MAA) for the product to the European Medicines Evaluation Agency. Nycomed has informed Diatide that it hopes to gain approval for AcuTect in the next 12 months.
AcuTect, formerly known as P280, is a technetium-labeled product for the detection and localization of acute venous thrombosis. Diatide filed a new drug application (NDA) for AcuTect with the Food and Drug Administration in September. The NDA was granted a priority rating, meaning that the agency intends to complete its review in six months.