Pharmaceutical company RepliGen Europe has withdrawn its application to the European Medicines Agency (EMA) for a centralized marketing authorization for SecreFlo.
SecreFlo was intended to be used as a contrast agent for MRI to improve pancreatic duct visualization for detecting duct abnormalities in patients with known or suspected pancreatitis.
In its withdrawal letter, RepliGen stated that the major objections raised by the EMA cannot be answered in the time period specified. The company had submitted its application on 2 February 2012, and it was under review by the agency's Committee for Medicinal Products for Human Use.
The withdrawal letter, and a document about SecreFlo and its state of scientific assessment at the time of application withdrawal, will be published on the EMA's website after 20 September 2012.
