Amersham's Myoview Gets FDA Go-Ahead

Amersham International of the UK has gained approval from the US Food and Drug Administration for Myoview (injectable technetium TC-99m tetrafosmin), its advanced heart imaging agent. The New Drug Application for Myoview was submitted to the FDA in 1992.

Amersham expects to launch the product there next month, and will market the radiopharmaceutical in the USA through its Medi-Physics division. Medi-Physics will distribute Myoview via a chain of 120 radiopharmacies and exclusive distributorships, which Amersham established across the USA last year. This network now rivals in size that offered by Syncor, which distributes a competitor product from DuPont Merck (see later).

Significant Approval Although the product has already been approved and launched in a number of countries worldwide, the US approval is significant as North America makes up the largest segment - about L140 million ($215 million) - of the total world cardiology imaging market, which is estimated at L250 million a year.