Nycomed’s Teslascan is approvable

May 28, 1997

Contrast agent developer Nycomed of Oslo, Norway, has received a second approvable letter from the Food and Drug Administration for its Teslascan (mangafodipir trisodium) liver imaging agent for MRI studies. Teslascan had received an approvable letter

Contrast agent developer Nycomed of Oslo, Norway, has received a second approvable letter from the Food and Drug Administration for its Teslascan (mangafodipir trisodium) liver imaging agent for MRI studies. Teslascan had received an approvable letter last September, but the FDA raised additional questions about the agent's application that the company has been working to resolve (SCAN 10/9/96). With the second approvable letter now in hand, Nycomed expects final approval shortly, according to a spokesperson for the company's U.S. subsidiary in Princeton, NJ.