Nycomed's Visipaque gains FDA okay

The Food and Drug Administration has approved a new drug applicationfor Hafslund Nycomed's Visipaque, the first in a new generationof dimeric-based x-ray contrast agents to be sold in the U.S.Nycomed, of Oslo, Norway, received the FDA's go-ahead last monthto commence U.S. sales.

Nycomed officials are expected to promote the isotonic characteristicsof Visipaque. Compared to conventional contrast media, Visipaquewas shown in clinical trials to reduce the incidence of patientdiscomfort during contrast-enhanced imaging procedures, a Nycomedofficial said. It was approved for general use in a broad rangeof indications.

Dimeric x-ray agents are under scrutiny in Europe, where Scheringhas pulled its Isovist 280 product off the market due to reportsof allergic reactions (SCAN 2/28/96). Nycomed officials say thatVisipaque has not experienced the problems Isovist 280 has encountered,and that the rate of allergic reactions to Visipaque is no higherthan those of other x-ray contrast media. Sales of Visipaque areunder way in 11 European countries, according to Nycomed.