MRI liver agent gains approvable letter

Nycomed secured an approvable letter from the Food and Drug Administrationon Sept. 12 for Teslascan, a new intravenous liver imaging agent.

The New York City-based subsidiary of Nycomed ASA of Oslo,Norway, is seeking regulatory clearance to market Teslascan (mangafodipirtrisodium) for use in MRI studies of adult patients to enhanceliver lesions, according to Carol Perlman, Nycomed vice presidentof corporate relations. Teslascan is known as S-095 in clinicaltrials.

The FDA acted relatively quickly on Nycomed's application,according to Perlman. An approvable letter for Teslascan was issued12 months after the company filed a new drug application for theagent, she said. In comparison, Advanced Magnetics in Cambridge,MA, gained an approvable letter for Feridex IV, another MR liveragent, 23 months after its NDA submission. Sales of Feridex commencedlast month, following FDA clearance (SCAN 9/11/96).

Receipt of an approvable letter is widely considered the finalhurdle to gaining the right to sell a new pharmaceutical productto U.S. customers. Agreement on language used in the labelingand package insert of Teslascan must still be worked out.

After approval, Teslascan will join Omniscan as the secondMRI agent in Nycomed's product line. Omniscan is a nonspecific,gadolinium-based agent, and has been sold in the U.S. since January1993.