FUJISAWA FILES NDA FOR PROGRAF

Fujisawa USA has submitted a New Drug Application to the US Food and Drug Administration for its immunosuppressive agent Prograf (tacrolimus: FK-506).

The drug, which is already approved in Japan, is intended to suppress the immune system to prevent rejection of organ transplants. Fujisawa presented two favorable extensive multi-center studies of tacrolimus, that were conducted in the USA and Europe, at the American Society of Transplant Surgeons meeting in Houston, Texas in May 1993.

Hatsuo Aoki, managing director of Fujisawa and chief executive of Fujisawa USA, said that "FK-506 is a key component of our strategy to expand our business in the US market. And we are encouraged by the multicenter studies' results."